Foam 10×12.5cm Pack 1
NPWT Foam Wound Dressings for use with RENASYS and PICO NPWT Systems. 10cmx13cm
8manufacturers in China registered for this device type
1catalogue number
35510(k) clearances naming this product code
20recalls on this code
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (2), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Zhejiang Longterm Medical Technology Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 26 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Devon Medical Products (Jiangsu) Ltd | Nantong | Jiangsu | Repacker / relabeller | 12 |
| Nantong MedTech Medical Products Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 6 |
| Lightstone Medical Products (Ningbo) Co Ltd | Ningbo | Zhejiang | Specification developer | 3 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | OMP |
| Device type | Negative Pressure Wound Therapy Powered Suction Pump |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4780 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K142979 |
| Record published | 2019-10-15 |
| Record revised | 2023-09-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66801021 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Pico | Smith & Nephew, Inc. | 57 |
| Negative Pressure Wound Therapy Powered Suction Pump | Carilex Medical, Inc. | 43 |
| DeRoyal | Deroyal Industries, Inc. | 34 |
| extriCARE | Oakwell Distribution, Inc. | 32 |
| Renasys | Smith & Nephew, Inc. | 27 |
| MicroDoc Npwt System | Pensar Medical | 26 |
| ExtriCARE | Alleva Medical Ltd | 22 |
| Vcare Alpha | I.V.T. Medical Ltd | 19 |
| V.A.C.® Granufoam™ | KCI USA, Inc. | 19 |
| Avance | Mölnlycke Health Care AB | 18 |
| Avance® Solo | Mölnlycke Health Care AB | 17 |
Showing 12 of 284. All products under Negative Pressure Wound Therapy Powered Suction Pump
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K260646 | 2026-05-27 |
| K251826 | 2025-09-11 |
| K243576 | 2025-02-18 |
| K231939 | 2024-05-24 |
| K223041 | 2022-11-22 |
| K202783 | 2022-01-14 |
| K211318 | 2022-01-05 |
| K202157 | 2020-10-30 |
| K191760 | 2019-12-05 |
| K181822 | 2019-03-21 |
| K182323 | 2019-01-18 |
| K181204 | 2019-01-10 |
| K180698 | 2018-08-21 |
| K180618 | 2018-04-20 |
| K180614 | 2018-04-06 |
| K172005 | 2018-02-02 |
| K172521 | 2017-09-20 |
| K172519 | 2017-09-15 |
| K163387 | 2017-04-18 |
| K152163 | 2016-09-29 |
| K162129 | 2016-08-31 |
| K153209 | 2016-08-04 |
| K151436 | 2016-01-28 |
| K143133 | 2015-07-23 |
| K151326 | 2015-07-16 |
| K142979 | 2015-04-29 |
| K132446 | 2013-10-23 |
| K112127 | 2012-05-16 |
| K111170 | 2011-12-15 |
| K110647 | 2011-06-22 |
| K102001 | 2010-08-06 |
| K091470 | 2009-07-09 |
| K083375 | 2009-02-25 |
| K082211 | 2008-11-14 |
| K082426 | 2008-09-05 |
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 |
|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2016-07-21 | Class II | Unknown/Undetermined by firm | Sterility seal integrity failures on the Renasys Sterile Transparent Film | 45,455 devices (in the USA) |
Recalls
17 of these are Class II. Class II means a temporary or reversible health consequence. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-10-02 | Class II | Process control | Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained. | 1589 units | |
| 2024-03-11 | Class II | Under Investigation by firm | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump | 6895 units | |
| 2024-03-11 | Class II | Under Investigation by firm | Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump | 675 units | |
| 2016-11-11 | Class II | No Marketing Application | Lack of 510k clearance for design modification. | 15,960 units in the US | |
| 2016-11-11 | Class II | No Marketing Application | Lack of 510k clearance for design modification. | 15,960 units (US ) | |
| 2014-08-13 | Class II | No Marketing Application | Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification. | 2,142 units | 2015-08-06 |
| 2014-07-18 | Class II | Device Design | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | 45,466 | 2015-08-05 |
| 2014-07-18 | Class II | Device Design | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | 19,499 = (10,849 (Item 66800058) & 8,650 (Item 66800913)) | 2015-08-05 |
| 2014-07-18 | Class II | Device Design | RENASYS EZ Canisters exhibiting visible evidence of deformation of the inlet port on the canister lid. | 77,164 = (75,619 (Item 66800423) & 1,545 (Item 66801066)) | 2015-08-05 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 28,250 individual units | 2014-09-26 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 7,353 individuals units | 2014-09-26 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 1,710,773 invididuals units | 2014-09-26 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 498,980 individuals units | 2014-09-26 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 15,754 indivdual units | 2014-09-26 |
| 2014-01-09 | Class II | Packaging change control | Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the | 162,629 invididual units | 2014-09-26 |
| 2013-11-14 | Class II | Device Design | Modification of the bacterial overflow guard (filter) and related changes to product labeling. | 6,799,140 canisters EZ & EZ PLUS | 2014-08-04 |
| 2013-11-14 | Class II | Device Design | Modification of the bacterial overflow guard (filter) and related changes to product labeling. | 6,871,375 canisters | 2014-08-04 |
| 2010-12-14 | Not classified | Nonconforming Material/Component | On 12/14/2010, Smith & Nephew, Inc. Wound Management Division in St. Petersburg, FL recalled their RENASYS PORT product code number 66800694 due to small holes in the primary pouch of some of the packaged units of which constituted a breach | 71329 units | 2012-04-30 |
| 2010-01-29 | Not classified | Other | Smith&Nephew Inc., Advance Wound Management, St Petersburg, FL is recalling their Ezcare Negative Pressure Wound Therapy pumps manufactured by BlueSky Medical Group Inc., between July 17, 2007 and December 13, 2007 and distributed by Smith& | 2717 units | 2010-11-10 |
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.