510(k) · Cleared
ClearedPICO Single Use Negative Pressure Wound Therapy System
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 Apr 18, 2017 as substantially equivalent to K112127 (Smith & Nephew, Inc., 2012) and 1 other predicate after a 137-day review. Its family tree reaches back 9 generations to 1995. 11 later devices descend from it.
- Decided
- Apr 18, 2017
- Review
- 137 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K945062 (1995). 24 ancestors in all, the oldest K933902 (1994). 11 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 2 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 1 generation backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- This deviceK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- Descendant · cites it directly · 8 of its ownK172005 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- Descendant · 2 generations on · 6 of its ownK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- Descendant · 3 generations on · 2 of its ownK191760 PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2019
- Descendant · 4 generations on · 1 of its ownK213906 extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd. · 2023
- Descendant · 3 generations on · 1 of its ownK202157 PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y…Smith & Nephew Medical Limited · 2020
Show all 9 generations
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 7 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 6 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 5 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 4 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 3 generations backK111170 PICOSmith & Nephew, Inc. · 2011
- 2 generations backK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- 1 generation backK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- This deviceK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · cites it directly8descendants
- K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · 2 generations on6descendants
- K191760PICO 14 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2019 · 3 generations on2descendants
- K213906extriCARE 1000 Negative Pressure Wound Therapy SystemAlleva Medical, Ltd. · 2023 · 4 generations on1descendant
- K202157PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative…Smith & Nephew Medical Limited · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −8 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −7 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −6 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −5 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −4 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −3 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| −2 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| −1 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| 0 (this device) | K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017 | — |
| +1 | 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 | — |
| +3 | K191760 | PICO 14 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2019 | — |
| +4 | K213906 | extriCARE 1000 Negative Pressure Wound Therapy System | Alleva Medical, Ltd. | 2023 | — |
| +3 | K202157 | PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use… | Smith & Nephew Medical Limited | 2020 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K112127 | Pico Single Use Negative Pressure Wound Therapy SystemSummary page 4…878.4780) Regulatory Class: Class II Product Code: OMP Predicate Device Information 510(k) Number: K112127 Device: PICO Single Use Negative Pressure Wound Therapy System =… | 2012 |
| * | K151436 | PICO Single Use Negative Pressure Wound Therapy SystemSummary page 5…em K163387 Page 2/6 Clearance Date: May 16, 2012 510(k) Number: K151436 Device: PICO Single Use Negative Pressure Wound Therapy… | 2016 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 24 ancestors have a recall of any class.
- Of its descendants, K172005 (Smith & Nephew Medical Limited, 2018) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K112127.
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. 2017, 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 is 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)
- Flaps and grafts
- Closed Surgical incisions
PICO Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163387 · printed Nov 4, 2026
Cite this page
510(k) Report. “K163387: PICO Single Use Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K163387
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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