510(k) · Cleared
Recalled · Class II · 2020Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardinalhealth · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Apr 20, 2015 as substantially equivalent to K111333 (Innovative Therapies, Inc., 2011) after a 182-day review. Its family tree reaches back 5 generations to 1995. 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 20, 2015
- Review
- 182 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945062 (1995). 7 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 4 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 3 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 2 generations backK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- 1 generation backK111333 Antlia Iii Wound Treatment SystemInnovative Therapies, Inc. · 2011
- This deviceK143016 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal…Cardinalhealth · 2015
- Descendant · cites it directly · 3 of its ownK150124 Cardinal Health NPWT PRO HCCardinalhealth · 2015
- Descendant · 2 generations on · 1 of its ownK161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT…Cardinalhealth · 2017
- Descendant · 3 generations on · 0 of its ownK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK171499 Occlusion Detection Dressing KitCardinalhealth · 2017
Most influential descendants
Showing 4 of 4 · See all- K150124Cardinal Health NPWT PRO HCCardinalhealth · 2015 · cites it directly3descendants
- K161418Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetCardinalhealth · 2017 · 2 generations on1descendant
- K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026 · 3 generations on0descendants
- K171499Occlusion Detection Dressing KitCardinalhealth · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −4 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −3 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −2 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| −1 | K111333 | Antlia Iii Wound Treatment System | Innovative Therapies, Inc. | 2011 | — |
| 0 (this device) | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT… | Cardinalhealth | 2015 | — |
| +1 | K150124 | Cardinal Health NPWT PRO HC | Cardinalhealth | 2015 | — |
| +2 | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation… | Cardinalhealth | 2017 | — |
| +3 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026 | — |
| +2 | K171499 | Occlusion Detection Dressing Kit | Cardinalhealth | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K111333 | Antlia Iii Wound Treatment SystemSummary page 4…ction Pump (21 CFR 878.4780) Regulatory Class: II Product Code: OMP III. Predicate Device 510(k) Number Device Name Submitter Name K111333 Antlia III WTS Innovative Therapies, I… | 2011 |
| † | K093564 | Sved Wound Treatment System | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150124 | Cardinal Health NPWT PRO HC | 2015 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2020 | Class II | Z-2544-2020 | Nonconforming Material/Component | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
| Jun 4, 2020 | Class II | Z-2543-2020 | Nonconforming Material/Component | Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K150124 (Cardinalhealth, 2015) has gone furthest, with 3 descendants of its own.
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. 2015, 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?
The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The systems are intended for use in acute, extended and home care settings.
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/K143016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143016: Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143016
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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