510(k) · Cleared
ClearedKevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kevo Medical Supplies · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jul 30, 2012 as substantially equivalent to K092992 (Genadyne Biotechnologies, Inc., 2010) after a 273-day review. Its family tree reaches back 6 generations to 1995. 10 later devices descend from it.
- Decided
- Jul 30, 2012
- Review
- 273 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. 10 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 backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 1 generation backK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- This deviceK113199 Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies · 2012
- Descendant · cites it directly · 9 of its ownK151261 Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia…Medela AG · 2015
- Descendant · 2 generations on · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK172145 Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure…Medela AG · 2018
- Descendant · 3 generations on · 2 of its ownK182409 Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019
- Descendant · 4 generations on · 1 of its ownK191460 PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG · 2015 · cites it directly9descendants
- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · 2 generations on8descendants
- K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG · 2018 · 3 generations on3descendants
- K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC · 2019 · 3 generations on2descendants
- K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC · 2019 · 4 generations on1descendant
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 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| 0 (this device) | K113199 | Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit | Kevo Medical Supplies | 2012 | — |
| +1 | K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam… | Medela AG | 2015 | — |
| +2 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | 1 |
| +3 | K172145 | Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound… | Medela AG | 2018 | — |
| +3 | K182409 | Applied Tissue Technologies PWD™ Platform Wound Dressing | Applied Tissue Technologies, LLC | 2019 | — |
| +4 | K191460 | PWD Platform Wound Dressing 3” x 5” Oblong | Applied Tissue Technologies, LLC | 2019 | — |
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 | 1 | 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 |
|---|---|---|---|
| * | K092992 | A4-XLR8 Foam DressingSummary page 1…807.92(a)(3) Company IBrand Name I 51 0(k) Number Genadyne Biotech nolog ies, Inc. A4-XLR8 Foam K092992 Dressing DEVICE DESCRIPTION 807.92(a)(4) The K… | 2010 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit… | 2015 | 9 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K151261 (Medela AG, 2015) has gone furthest, with 9 descendants of its own.
- 7 other devices also cite its predicate K092992.
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. 2012, 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?
Kevo NPWT- acHemo3O Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- cxHemo3O Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris. Kevo NPWT- axHemo3O Foam Dressing Kit is…
Read the full statement (120 words)
Kevo NPWT- acHemo3O Foam Dressing Kit is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Kevo NPWT- cxHemo3O Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.
Kevo NPWT- axHemo3O Foam Dressing Kit is appropriate for use on the following wounds:
* Pressure Ulcers
* Diabetic/Neuropathic Ulcers
* Venous Insufficiency Ulcers
* Traumatic Wounds
* Post-Operative and Dehisced Surgical Wounds
* Skin Flaps and Grafts
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113199 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113199: Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113199
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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