Sterrad™
STERRAD™ 100NX Sterilization System with ALLClear™ Technology, 1-Door with DUO
2manufacturers in China registered for this device type
18catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ningbo Incote Precision Machinery Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 2 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
Record
| Listed by | Advanced Sterilization Products Services Inc. |
|---|---|
| FDA product code | MLR |
| Device type | Sterilizer, Chemical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6860 |
| 510(k) | K111377 |
| Record published | 2021-07-19 |
| Record revised | 2025-12-23 (version 15) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 14.8 to 31.3 Inches of Mercury; Storage environment temperature -29 to 70 °C; Special storage condition: Humidity – including condensing |
| Packaging | Case of 5, case of 2 |
| Distribution end date | 2024-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10137V | In distribution | |
| 10104-010 | In distribution | |
| 10104-009 | In distribution | |
| 10104-006 | In distribution | |
| 10133 | In distribution | |
| 20250 | In distribution | |
| 10104-005 | In distribution | |
| 10134V | In distribution | |
| 10104-007 | In distribution | |
| 10104-008 | In distribution | |
| 10144 | In distribution | |
| 10104-003 | Withdrawn | |
| 10104-002 | Withdrawn | |
| 10104-004 | Withdrawn | |
| 10207 | Withdrawn | |
| 10208 | Withdrawn | |
| 10104 | Withdrawn | |
| 10113 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trilogy® | Zimmer, Inc. | 274 |
| NexGen® | Zimmer, Inc. | 15 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 10 |
| V-PRO | Steris Mexico, S. de R.L. de C.V. | 7 |
| Amsco V-PRO | Steris Mexico, S. de R.L. de C.V. | 6 |
| SteroScope Insert Connector Large Assembly, Type 3, Qty 1 | Ideate Medical | 4 |
| Vaprox | Steris Corporation | 4 |
| Sterilink™ | Plasmapp Co., Ltd. | 3 |
| SteroScope Insert Connector Extra Small Assembly, Type R2, Qty 1 | Ideate Medical | 2 |
| Sterlink™ | Plasmapp Co., Ltd. | 2 |
| SteroScope Biopsy Connector Assembly, Type R1, Qty 1 | Ideate Medical | 2 |
| Sterrad NX™ | Advanced Sterilization Products Services Inc. | 2 |
Showing 12 of 34. All products under Sterilizer, Chemical
Recalls Naming This Product
28 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Advanced Sterilization Products | 510(k) number | 2017-01-09 | Class II | Software design | Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration. | 7,694 units total (5,935 units in US) | 2017-11-02 |
| Advanced Sterilization Products | 510(k) number | 2015-07-17 | Class II | Under Investigation by firm | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states “APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indica | 1465 units | 2016-05-20 |
| Advanced Sterilization Products | 510(k) number | 2014-11-04 | Class II | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | 19,978 units total (9,792 units in US) | 2015-08-04 |
| Advanced Sterilization Products | 510(k) number | 2014-11-04 | Class II | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | 19,978 units total (9,792 units in US) | 2015-08-04 |
| Advanced Sterilization Products | 510(k) number | 2014-11-04 | Class II | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | 19,978 units total (9,792 units in US) | 2015-08-04 |
| Advanced Sterilization Products | 510(k) number | 2014-11-04 | Class II | Nonconforming Material/Component | Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. | 19,978 units total (9,792 units in US) | 2015-08-04 |
| Advanced Sterilization Products | 510(k) number | 2013-12-16 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | 5584 units | 2014-03-27 |
| Advanced Sterilization Products | 510(k) number | 2013-12-16 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | 233 units | 2014-03-27 |
| Advanced Sterilization Products | 510(k) number | 2013-12-16 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems. | 2366 units | 2014-03-27 |
| Advanced Sterilization Products | 510(k) number | 2013-11-11 | Class II | Labeling design | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not list | Total 4,381 units | 2014-01-22 |
| Advanced Sterilization Products | 510(k) number | 2013-11-11 | Class II | Labeling design | Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not list | Total 4,381 units | 2014-01-22 |
| Advanced Sterilization Products | 510(k) number | 2013-09-18 | Class II | Under Investigation by firm | Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette’s labeled | 2,995 units | 2014-01-13 |
| Advanced Sterilization Products | 510(k) number | 2013-07-25 | Class II | Under Investigation by firm | The recall of the STERRAD 100NX Cassettes was initiated because Advanced Sterilization Products (ASP) does not have adequate data to support the effectiveness of the packaging’s leak indicator for the entire duration of the STERRAD 100 NX S | 1,923 units | 2013-11-27 |
| Advanced Sterilization Products | 510(k) number | 2013-03-22 | Class II | Nonconforming Material/Component | The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal oper | 1500 units | 2013-09-30 |
| Advanced Sterilization Products | 510(k) number | 2012-06-19 | Class III | Error in labeling | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STER | 7,495 units | 2013-11-08 |
| Advanced Sterilization Products | 510(k) number | 2012-06-19 | Class III | Error in labeling | Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STER | 7,550 units | 2013-11-08 |
| Advanced Sterilization Products | 510(k) number | 2009-03-09 | Not classified | Component design/selection | ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs. | 2,209 units installed in US; 2013 units OUS | 2012-03-14 |
| Advanced Sterilization Products | 510(k) number | 2009-03-09 | Not classified | Component design/selection | ASP has identified a secondary, lower-occurring cause of oil mist within certain STERRAD NX Systems and STERRAD 50 Systems due to potentially defective oil fill plugs. | 2,209 units installed in US; 2013 units OUS | 2012-03-14 |
| Advanced Sterilization Products | 510(k) number | 2008-12-10 | Not classified | Error in labeling | Advanced Sterilization Products (ASP) has discovered a defect in the barcode labeling of the STERRAD NX System Cassettes 10133, Lot #08I032. This is the only lot number affected by this action. The barcodes for Lot #08I032 were printed impr | 776 cases | 2011-12-16 |
| Advanced Sterilization Products | 510(k) number | 2008-10-17 | Not classified | Component design/selection | 1) Inability of the sterilizer to detect when an injection takes place without hydrogen peroxide being transferred to the vaporizer bowl. This situation can result in a cycle completion with the injection of insufficient hydrogen peroxide | In the U.S., there are 2,623 units installed. There are also | 2011-11-29 |
| Advanced Sterilization Products | 510(k) number | 2008-10-07 | Not classified | Nonconforming Material/Component | ASP has discovered a component defect in some of the UV lamp power supplies used in certain STERRAD NX Sterilizers. This defect can potentially cause the Hydrogen Peroxide Monitor to give inaccurate readings. | 32 potentially affected systems in the US – 20 installed, 5 | 2011-11-07 |
| Advanced Sterilization Products | 510(k) number | 2008-02-25 | Not classified | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, “haze,” or “smoke.” | 9,950 | 2011-11-21 |
| Advanced Sterilization Products | 510(k) number | 2008-02-25 | Not classified | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, “haze,” or “smoke.” | 9,950 | 2011-11-21 |
| Advanced Sterilization Products | 510(k) number | 2008-02-25 | Not classified | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, “haze,” or “smoke.” | 9,950 | 2011-11-21 |
| Advanced Sterilization Products | 510(k) number | 2008-02-25 | Not classified | Device Design | Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, “haze,” or “smoke.” | 9,950 | 2011-11-21 |
| Advanced Sterilization Products | 510(k) number | 2007-11-12 | Not classified | Other | Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities | 9,686 units | 2011-12-19 |
| Advanced Sterilization Products | 510(k) number | 2007-11-12 | Not classified | Employee error | User Guide Update: based on user reports about contact with residual hydrogen peroxide from instruments, pouches and trays after sterilization and subsequent light colored residue on these devices after sterilization updated user guidance h | 9,686 units total for recalls Z-0845-0848-2008 | 2012-03-14 |
| Advanced Sterilization Products | 510(k) number | 2005-09-16 | Not classified | Other | The STERRAD 100 and the STERRAD 100S vaporizer plates are prone to displacement allowing micro-droplets of H2O2 to contact the load. If the vaporizer plate is dislodged, there is an increased chance for operators to have contact with H2O2 r | 5365 | 2011-11-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.