Celerity
The Celerity 5 HP Biological Indicator is used for routine monitoring of certain cycles of the V-PRO 1, 1 Plus, maX, maX2, 60, s2 Low Temperature Sterilization Systems, STERRAD 100S…
The Celerity 5 HP Biological Indicator is used for routine monitoring of certain cycles of the V-PRO 1, 1 Plus, maX, maX2, 60, s2 Low Temperature Sterilization Systems, STERRAD 100S Sterilizer, STERRAD NX with or without ALLCLEAR, STERRAD 100NX with or without ALLCLEAR and when used in conjunction with the Celerity Incubator, the incubator provides a fluorescent result within 5 minutes.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Steris Corporation, United States |
|---|---|
| FDA product code | FRC |
| Device type | Indicator, Biological Sterilization Process |
| Device class | Class 2 |
| Regulation | 21 CFR 880.2800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K223717 |
| Record published | 2023-08-08 |
| Record revised | 2022-04-25 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment humidity 30 to 60 % RH; Storage environment temperature 60 to 75 °F |
| Distribution end date | 2022-04-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| LCB052 | 25 | In distribution | |
| LCB049 | 25 | In distribution | |
| LCB060 | In distribution | ||
| LCB048 | 25 | In distribution | |
| LCB044 | 25 | In distribution | |
| Incubator | In distribution | ||
| LCB058 | 25 | In distribution | |
| LCB053 | 25 | In distribution | |
| LCB045 | 5 | In distribution | |
| LCB059 | 5 | In distribution | |
| LCB050 | 25 | In distribution | |
| Incubator | In distribution | ||
| LCB054 | 30 | In distribution | |
| LCB051 | Withdrawn | ||
| LCB046 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bionova® | Terragene S.A. | 47 |
| Attest™ | 3M Company | 36 |
| Verify | Steris Corporation | 27 |
| 3M™ Attest™ | 3M Company | 16 |
| Biotrace™ | Terragene S.A. | 11 |
| Single Species BI Strip | Crosstex International | 11 |
| Tuttnauer® | Terragene S.A. | 10 |
| Sterrad Velocity™ | Advanced Sterilization Products Services Inc. | 8 |
| GPS | Group Practice Solutions | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Propper Duo Spore Biological Indicators | Propper Manufacturing Co., Inc. | 7 |
| Spore Strip Steam & Chemiclave | Mesa Laboratories, Inc. | 6 |
Showing 12 of 173. All products under Indicator, Biological Sterilization Process
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260766 | 2026-04-08 |
| K252680 | 2025-09-24 |
| K251452 | 2025-06-06 |
| K250061 | 2025-02-06 |
| K250044 | 2025-02-06 |
| K233681 | 2023-12-15 |
| K231490 | 2023-08-07 |
| K223715 | 2023-06-15 |
| K223717 | 2023-06-15 |
| K213881 | 2022-07-21 |
| K220473 | 2022-03-18 |
| K202721 | 2021-01-08 |
| K200126 | 2020-05-22 |
| K190297 | 2019-05-14 |
| K183294 | 2019-01-03 |
| K181686 | 2018-07-24 |
| K181429 | 2018-06-13 |
| K173488 | 2018-03-01 |
| K173633 | 2018-02-28 |
| K173629 | 2018-02-21 |
| K173626 | 2018-02-21 |
| K173670 | 2018-02-12 |
| K173634 | 2018-02-12 |
| K172752 | 2018-02-09 |
| K172474 | 2017-12-29 |
| K171587 | 2017-08-22 |
| K171504 | 2017-08-22 |
| K170070 | 2017-04-28 |
| K140499 | 2014-07-17 |
| K140708 | 2014-06-16 |
| K092906 | 2009-12-30 |
| K083665 | 2009-09-01 |
| K090514 | 2009-03-16 |
| K073618 | 2009-01-07 |
| K073244 | 2008-05-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Mckesson Medical-Surgical Inc. Corporate Office | 510(k) number | 2022-05-25 | Class III | Environmental control | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. | a. 10 bx, b. 20 bx, c. 7 bx, d. 6 bx, e. 18 bx, f. 1 |
Recalls
5 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 105 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 857 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 60 boxes | |
| 2022-12-12 | Class II | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to mo | 338 boxes | |
| 2013-09-10 | Class II | Use error | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a resul | 1,238 boxes | 2014-02-14 |
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.