Pico
Smith+Nephew PICO is a single-use negative-pressure wound therapy system built around a compact pump and a dressing. The pump creates negative pressure across the dressing, while the…
Smith+Nephew PICO is a single-use negative-pressure wound therapy system built around a compact pump and a dressing. The pump creates negative pressure across the dressing, while the dressing collects wound fluid and transmits the therapy to the wound area.
The filed example pairs a PICO system with a 25 by 25 cm dressing. Smith+Nephew describes PICO as a family of pump and dressing configurations for use on open wounds and closed surgical incisions.
Listed Item
PICO Single Use Negative Pressure Wound Therapy System 25cm x 25cm 10in. X 10in.
Pump and Dressing
The pump applies negative pressure through the dressing, which covers the wound or incision and manages exudate. The dressing forms the interface between the treatment area and the pump.
PICO configurations pair pumps with different dressing sizes and shapes. The listed set is one such pairing; the dressing and pump operate together as the single-use system.
8manufacturers in China registered for this device type
57catalogue numbers in this listing
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) | K182323 |
| Record published | 2018-08-23 |
| Record revised | 2023-09-07 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Cas of 3, car of 5, cas of 5, case of 3, case |
| Sizes | Length 5.9 to 15.699 in; width 3.8999 to 9.8 in; length 15 to 40 cm; width 10 to 25 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66022012 | Length 7.9000 in | In distribution |
| 66022015 | Length 5.9000 in | In distribution |
| 66002000 | Width 5.9000 in | In distribution |
| 66022014 | Width 10 cm | In distribution |
| 66022006 | Width 15 cm | In distribution |
| 66022019 | Length 25 cm | In distribution |
| 66022005 | Width 5.9000 in | In distribution |
| 66002006 | Width 5.9000 in | In distribution |
| 66021360 | In distribution | |
| 66022022 | Length 20 cm | In distribution |
| 66022027 | Width 5.9000 in | In distribution |
| 66021361 | In distribution | |
| 66800958 | In distribution | |
| 66002004 | Width 10 cm | In distribution |
| 66022023 | Length 11.800 in | In distribution |
| 66021365 | In distribution | |
| 66800956 | In distribution | |
| 66002009 | Width 9.8000 in | In distribution |
| 66800953 | In distribution | |
| 66021363 | In distribution | |
| 66022020 | Width 15 cm | In distribution |
| 66022016 | Width 5.9000 in | In distribution |
| 66022017 | Width 5.9000 in | In distribution |
| 66022010 | Length 7.9000 in | In distribution |
| 66021362 | In distribution | |
| 66022028 | Length 20 cm | In distribution |
| 66021364 | In distribution | |
| 66002005 | Length 5.9000 in | In distribution |
| 66800952 | In distribution | |
| 66022018 | Width 7.9000 in | In distribution |
| 66022004 | Width 10 cm | In distribution |
| 66022011 | Length 9.8000 in | In distribution |
| 66800954 | In distribution | |
| 66022007 | Width 5.9000 in | In distribution |
| 66022025 | Length 5.9000 in | In distribution |
| 66002001 | Length 9.8000 in | In distribution |
| 66021358 | In distribution | |
| 66022009 | Width 25 cm | In distribution |
| 66002008 | Width 7.9000 in | In distribution |
| 66800955 | In distribution | |
| 66002003 | Length 11.9 in | In distribution |
| 66022001 | Length 25 cm | In distribution |
| 66800957 | In distribution | |
| 66022029 | Width 25 cm | In distribution |
| 66021359 | In distribution | |
| 66800951 | In distribution | |
| 66022003 | Length 30 cm | In distribution |
| 66022002 | Length 7.9000 in | In distribution |
| 66022000 | Width 5.9000 in | In distribution |
| 66022008 | Width 7.9000 in | In distribution |
| 66022024 | Width 10 cm | In distribution |
| 66002002 | Length 20 cm | In distribution |
| 66002007 | Length 11.800 in | In distribution |
| 66022026 | Width 5.9000 in | In distribution |
| 66022031 | Width 20 cm | In distribution |
| 66022013 | Length 11.800 in | In distribution |
| 66022021 | Length 25 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 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 |
| Silverlon Antimicrobial Wound Dressing | Argentum Medical, LLC | 14 |
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
18 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 ) | |
| 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) | |
| 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.