510(k) · Cleared
ClearedCardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set
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 Jan 19, 2017 as substantially equivalent to K150124 (Cardinalhealth, 2015) after a 241-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Jan 19, 2017
- Review
- 241 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K945062 (1995). 9 ancestors in all. 1 later device descends from it, 1 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 backK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- 3 generations backK111333 Antlia Iii Wound Treatment SystemInnovative Therapies, Inc. · 2011
- 2 generations backK143016 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal…Cardinalhealth · 2015 · Recalled
- 1 generation backK150124 Cardinal Health NPWT PRO HCCardinalhealth · 2015
- This deviceK161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT…Cardinalhealth · 2017
- Descendant · cites it directly · 0 of its ownK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026 · cites it directly0descendants
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 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| −3 | K111333 | Antlia Iii Wound Treatment System | Innovative Therapies, Inc. | 2011 | — |
| −2 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT… | Cardinalhealth | 2015 | 2 |
| −1 | K150124 | Cardinal Health NPWT PRO HC | Cardinalhealth | 2015 | — |
| 0 (this device) | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation… | Cardinalhealth | 2017 | — |
| +1 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K150124 | Cardinal Health NPWT PRO HCSummary page 4…ed Suction Pump (21 CFR 878.4780) Regulatory Class: II Product Code: OMP III. Predicate Device Primary: K150124 Cardinal Health NPWT PRO HC This predicate has not been subject to a design-related recall.… | 2015 |
| † | K142916 | SVED Wound Treatment System | 2015 |
| † | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT PRO at Home | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261338 | RENASYS DYNAFLOW Kit (66807741) | 2026 | 0 |
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 4 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K261338 (Smith & Nephew Medical, Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K150124.
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?
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are 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 fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with…
Read the full statement (118 words)
The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are 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 fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care 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/K161418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161418: Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161418
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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