510(k) · Cleared
ClearedPICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith Nephew Medical Limited · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 5, 2022 as substantially equivalent to K202157 (Smith & Nephew Medical Limited, 2020) after a 250-day review. Its family tree reaches back 13 generations to 1995.
- Decided
- Jan 5, 2022
- Review
- 250 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K945062 (1995). 28 ancestors in all, the oldest K933902 (1994). No later device cites it as a predicate yet.
- Root · 13 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 9 generations between
- 3 generations backK172005 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 2 generations backK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 1 generation backK202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y…Smith & Nephew Medical Limited · 2020
- This deviceK211318 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14…Smith Nephew Medical Limited · 2022
Show all 13 generations
- Root · 13 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 12 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 11 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 10 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 9 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 8 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 7 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 6 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 5 generations backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- 4 generations backK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- 3 generations backK172005 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 2 generations backK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- 1 generation backK202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y…Smith & Nephew Medical Limited · 2020
- This deviceK211318 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14…Smith Nephew Medical Limited · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −12 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −11 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −10 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −9 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −8 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −7 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −6 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −5 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| −4 | K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017 | — |
| −3 | K172005 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018 | — |
| −2 | K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018 | — |
| −1 | K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use… | Smith & Nephew Medical Limited | 2020 | — |
| 0 (this device) | K211318 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use… | Smith Nephew Medical Limited | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OMP device
- #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Summary page 4…gulation 21 CFR 878.4780 Number Regulatory Class Class II Product Code OMP 21 CFR 807.92 (a)(3): Legally 510(k) Number: K202157 marketed device to Device Name: PICO 7 Single Use Negative Pressure Wound Therapy which equivalence System is claimed… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 6 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 28 ancestors have a recall of any class.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
What is it indicated for?
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: * Chronic » Acute * Traumatic * Subacute and dehisced wounds »…
Read the full statement (145 words)
PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System and PICO Fluid Management Packs are indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include:
* Chronic
» Acute
* Traumatic
* Subacute and dehisced wounds
» Partial-thickness burns
* Ulcers (such as diabetic or pressure)
o Venous Leg Ulcers — PICO can be used in combination with Graduated Compression Therapy in the management of Venous Leg Ulcers
» Flaps and grafts
* Closed surgical incisions
PICO 7 Single Use Negative Pressure Wound Therapy Systems, PICO 14 Single Use Negative Pressure Wound Therapy Systems and PICO Fluid Management Packs are suitable for use in both a hospital and homecare setting.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K211318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211318: PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211318
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026