510(k) · Cleared
ClearedPICO
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 Dec 15, 2011 as substantially equivalent to K080275 (Iasis Medical, Inc., 2008) and 2 other predicates after a 233-day review. Its family tree reaches back 6 generations to 1995. 26 later devices descend from it.
- Decided
- Dec 15, 2011
- Review
- 233 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945062 (1995). 21 ancestors in all, the oldest K933902 (1994). 26 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 4 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 3 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 2 generations backK082426 Renasys EZSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- This deviceK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 2 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · 2 generations on · 11 of its ownK163387 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017
- Descendant · 3 generations on · 8 of its ownK172005 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
- Descendant · 3 generations on · 6 of its ownK180698 PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · cites it directly25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 2 generations on23descendants
- K163387PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2017 · 2 generations on11descendants
- K172005PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · 3 generations on8descendants
- K180698PICO 7 Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical Limited · 2018 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −4 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −3 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −2 | K082426 | Renasys EZ | Smith & Nephew, Inc. | 2008 | 4 |
| −1 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| 0 (this device) | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +1 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +2 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| +2 | 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 | — |
| +3 | K180698 | PICO 7 Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical Limited | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 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…Classification/Code: Class II, OMP 4. Date summary prepared: December 15, 2011 5. Predicate Device Information: NPD 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical 6393 Oakgreen Avenue Hastings, MN 55033 Renasys Go (K083375) Smith & Nephew Inc, St. Petesbu… | 2008 |
| * | K083375 | Renasys GO Negative Pressure Wound TherapySummary page 1…icate Device Information: NPD 1000 Negative Pressure Wound Therapy System (K080275) Kalypto Medical 6393 Oakgreen Avenue Hastings, MN 55033 Renasys Go (K083375) Smith & Nephew Inc, St. Petesburg, FL (fUI Prevena I… | 2009 |
| * | K100821 | Prevena Incision Management SystemSummary page 2…s Go (K083375) Smith & Nephew Inc, St. Petesburg, FL (fUI Prevena Incision Management System (K1 00821) KCI USA, INC. 6203 Farinon Dr. San Antonio, TX 78249 6. Device Description: PICO Single Use Negative Pressure Wound Therapy… | 2010 |
What descends from it? (26)
See all 261 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112127 | Pico Single Use Negative Pressure Wound Therapy System | 2012 | 25 |
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 16 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 10 of the 21 ancestors have a recall of any class.
- Of its descendants, K112127 (Smith & Nephew, Inc., 2012) has gone furthest, with 25 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. 2011, 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. Product Codes: 66800862, 66800863,66800865 and 66800866 are indicated for use on low and moderately exuding wounds. Examples of appropriate wound types include: Chronic Acute Traumatic Subacute and dehisced wounds Partial-thickness burns Ulcers…
Read the full statement (188 words)
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.
Product Codes: 66800862, 66800863,66800865 and 66800866 are indicated for use on low and moderately exuding wounds.
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 in both a hospital and homecare setting.
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 levels of exudate and infectious materials.
Product Codes: 66800664, 66800867,66800868 and 66800869 are indicated for use on low exuding wounds,
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 in both a hospital and homecare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111170 · printed Nov 3, 2026
Cite this page
510(k) Report. “K111170: PICO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K111170
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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