510(k) · Cleared
ClearedRENASYS DYNAFLOW Kit (66807741)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Medical, Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 11, 2026 as substantially equivalent to K161418 (Cardinalhealth, 2017) and 1 other predicate after a 141-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 11, 2026
- Review
- 141 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K945062 (1995). 17 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 6 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 5 generations backK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- 4 generations backK111333 Antlia Iii Wound Treatment SystemInnovative Therapies, Inc. · 2011
- 3 generations backK143016 Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal…Cardinalhealth · 2015 · Recalled
- 2 generations backK150124 Cardinal Health NPWT PRO HCCardinalhealth · 2015
- 1 generation backK161418 Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT…Cardinalhealth · 2017
- This deviceK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −6 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −5 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| −4 | K111333 | Antlia Iii Wound Treatment System | Innovative Therapies, Inc. | 2011 | — |
| −3 | K143016 | Cardinal Health NPWT PRO, Cardinal Health NPWT PRO to Go, Cardinal Health NPWT… | Cardinalhealth | 2015 | 2 |
| −2 | K150124 | Cardinal Health NPWT PRO HC | Cardinalhealth | 2015 | — |
| −1 | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation… | Cardinalhealth | 2017 | — |
| 0 (this device) | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | K161418 | Cardinal Health NPWT Irrigation Tubing Set, Cardinal Health NPWT Irrigation Delivery SetSummary page 5…Suction Pump 21 CFR 807.92 (a)(3): Legally marketed device to which equivalence is claimed K161418 (Primary Predicate) 510(k) Number K203316… | 2017 |
| * | K203316 | V.A.C.ULTA Negative Pressure Wound Therapy SystemSummary page 5…lence is claimed K161418 (Primary Predicate) 510(k) Number K203316 Cardinal Health NPWT Irrigation Tubing Set Device Name… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 5 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 17 ancestors have a recall of any class.
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. 2026, 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 RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material). For patients who would benefit from vacuum assisted drainage and controlled…
Read the full statement (114 words)
The RENASYS DYNAFLOW system is intended to be used in conjunction with Smith + Nephew RENASYS EDGE and RENASYS TOUCH NPWT for the application of negative pressure wound therapy to the wound to promote wound management by the delivery of saline to the wound bed and removal of fluids (including saline, irrigation fluids, body fluids, wound exudates and infectious material).
For patients who would benefit from vacuum assisted drainage and controlled delivery of saline over the wound bed.
The RENASYS DYNAFLOW device is intended for use in the clinical setting by clinicians.
Appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure and diabetic), partial-thickness burns, flaps, and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261338 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261338: RENASYS DYNAFLOW Kit (66807741).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261338
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026