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, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on May 16, 2012 as substantially equivalent to K080275 (Iasis Medical, Inc., 2008) and 2 other predicates after a 296-day review. Its family tree reaches back 7 generations to 1995. 25 later devices descend from it.
- Decided
- May 16, 2012
- Review
- 296 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K945062 (1995). 22 ancestors in all, the oldest K933902 (1994). 25 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 3 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- 1 generation backK111170 PICOSmith & Nephew, Inc. · 2011
- This deviceK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · cites it directly · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 11 of its ownK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- Descendant · 2 generations on · 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 · 2 generations on · 4 of its ownK161599 UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · cites it directly23descendants
- K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017 · cites it directly11descendants
- K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · 2 generations on8descendants
- K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · 2 generations on6descendants
- K161599UNO Negative Pressure Wound Therapy SystemGenadyne Biotechnologies, Inc. · 2017 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −6 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −5 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −4 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −3 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −2 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| −1 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| 0 (this device) | 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 | — |
| +1 | K163387 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2017 | — |
| +2 | 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 | — |
| +2 | K161599 | UNO Negative Pressure Wound Therapy System | Genadyne Biotechnologies, Inc. | 2017 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K080275 | NPD 1000 Negative Pressure Wound Therapy SystemSummary page 1…) Product Classification/Code: Class II, OMP 4. Date Prepared: May. 15, 2012 5. Predicate Device Information: NPID 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical 6393 Oakgreen Avenue Hastings, MN 55033 Renasys Go (K083375) Smith & Nephew, Inc. St. Petersburg, F… | 2008 |
| * | K083375 | Renasys GO Negative Pressure Wound TherapySummary page 1…Predicate Device Information: NPID 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical 6393 Oakgreen Avenue Hastings, MN 55033 Renasys Go (K083375) Smith & Nephew, Inc. St. Petersburg, FL PICO Single Use Negative Pressure Wound Therapy System (K1 11170) Smith & Nephe… | 2009 |
| * | K111170 | PICO Cleared while this submission was under review Summary page 1…6393 Oakgreen Avenue Hastings, MN 55033 Renasys Go (K083375) Smith & Nephew, Inc. St. Petersburg, FL PICO Single Use Negative Pressure Wound Therapy System (K1 11170) Smith & Nephew, Inc. St, Petersburg, FL… | 2011 |
What descends from it? (25)
See all 253 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 17 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 22 ancestors have a recall of any class.
- Of its descendants, K151436 (Smith & Nephew Medical, Ltd., 2016) has gone furthest, with 23 descendants of its own.
- 3 other devices also cite its predicate K080275.
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. 2012, 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.
Examples of 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/K112127 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112127: 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 6, 2026. https://510kreport.com/device/K112127
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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