510(k) · Cleared
ClearedKci NPWT Gauze Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Apr 4, 2013 as substantially equivalent to K110647 (Smith & Nephew, Inc., 2011) after a 142-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Apr 4, 2013
- Review
- 142 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K945062 (1995). 9 ancestors in all. 11 later devices descend from it, 3 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 backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- This deviceK123507 Kci NPWT Gauze DressingKci USA, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · 2 generations on · 2 of its ownK182409 Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019
- Descendant · 3 generations on · 1 of its ownK191460 PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK254019 Wound Geni NPWT SystemBechtel Medical, Inc. · 2026
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · cites it directly8descendants
- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · 2 generations on3descendants
- K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019 · 2 generations on2descendants
- K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019 · 3 generations on1descendant
- K254019Wound Geni NPWT SystemBechtel Medical, Inc. · 2026 · 3 generations on0descendants
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 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −1 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| 0 (this device) | K123507 | Kci NPWT Gauze Dressing | Kci USA, Inc. | 2013 | — |
| +1 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | 1 |
| +2 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +2 | K182409 | Applied Tissue Technologies PWD™ Platform Wound Dressing | Applied Tissue Technologies, LLC | 2019 | — |
| +3 | K191460 | PWD Platform Wound Dressing 3” x 5” Oblong | Applied Tissue Technologies, LLC | 2019 | — |
| +3 | K254019 | Wound Geni NPWT System | Bechtel Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Summary page 1…Leg1y~' Smith and Nephew's RENASYS' m Gauze NPWT Wound Dressing Kit with rnrketed U-- Softport 'd~de~s) at>51 0(k) Number: K1 10647 Devic dresising) *One V.AC. SensaT.R.A. C. TM Pad (conn… | 2011 |
What descends from it? (11)
See all 113 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 18 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K170088 (Medela AG, 2017) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K110647.
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. 2013, 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 KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.0, lnfoV.A.C.0, V.AC. SimplicityTM, V.A.C.0 Freedom, V.AC. ATSO and V.A.C.Uta TM Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing…
Read the full statement (112 words)
The KCI NPWT Gauze Dressing is intended to be used with the following KCI Therapy Units (ActiV.A.C.0, lnfoV.A.C.0, V.AC. SimplicityTM, V.A.C.0 Freedom, V.AC. ATSO and V.A.C.Uta TM Therapy Systems). The system is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Wound types include chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The KCl NPWT Gauze Dressing is not intended for use with instillation therapy, intermittent therapy or over closed incisions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123507 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123507: Kci NPWT Gauze Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123507
Report an extraction error
Are you the manufacturer?
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