510(k) · Cleared
ClearedA4-XLR8 Foam Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genadyne Biotechnologies, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jun 29, 2010 as substantially equivalent to K082211 (Smith & Nephew, Inc., 2008) after a 274-day review. Its family tree reaches back 5 generations to 1995. 31 later devices descend from it.
- Decided
- Jun 29, 2010
- Review
- 274 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K945062 (1995). 8 ancestors in all. 31 later devices descend from it, 8 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 backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 1 generation backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- This deviceK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
- Descendant · cites it directly · 10 of its ownK113199 Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies · 2012
- Descendant · 2 generations on · 9 of its ownK151261 Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia…Medela AG · 2015
- Descendant · 3 generations on · 8 of its ownK170088 Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with…Medela AG · 2017 · Recalled
- Descendant · cites it directly · 5 of its ownK140022 Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister…Cork Medical Products, LLC · 2014
- Descendant · cites it directly · 4 of its ownK133333 Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT…Blue Ocean Medical Product, LLC · 2014
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K113199Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing KitKevo Medical Supplies · 2012 · cites it directly10descendants
- K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG · 2015 · 2 generations on9descendants
- K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG · 2017 · 3 generations on8descendants
- K140022Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT…Cork Medical Products, LLC · 2014 · cites it directly5descendants
- K133333Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing KitBlue Ocean Medical Product, LLC · 2014 · cites it directly4descendants
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 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −1 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| 0 (this device) | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
| +1 | K113199 | Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit | Kevo Medical Supplies | 2012 | — |
| +2 | K151261 | Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam… | Medela AG | 2015 | — |
| +3 | K170088 | Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad… | Medela AG | 2017 | 1 |
| +1 | K140022 | Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus… | Cork Medical Products, LLC | 2014 | — |
| +1 | K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing… | Blue Ocean Medical Product, LLC | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSummary page 1…ivalent Device Company Product 510(k) # Smith & Nephew, Inc. RenaSySTM-F NPWT Foam Dressing K08221 1 DEVICE DESCRIPTION 807.92(a)(4) Genadyne A4-XLR8 Foam Dressing is manufactured using a… | 2008 |
What descends from it? (31)
See all 318 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113199 | Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit | 2012 | 10 |
| K140022 | Nisus Negative Pressure Wound Therapy Pump, Nisus NPWT Canister 250-ML, Nisus NPWT… | 2014 | 5 |
| K133333 | Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit, Uni NPWT Foam Dressing Kit | 2014 | 4 |
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam… | 2014 | 4 |
| K142646 | XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and | 2015 | 1 |
| K132004 | NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large | 2014 | 1 |
| K141961 | Genadyne Spiro Foam Dressing Kit | 2015 | 0 |
| K132936 | Novopore Dressing | 2014 | 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 15 years and passes through 4 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 8 ancestors have a recall of any class.
- Of its descendants, K113199 (Kevo Medical Supplies, 2012) has gone furthest, with 10 descendants of its own.
- 4 other devices also cite its predicate K082211.
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. 2010, 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?
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris. A4-XLR8 Foam Dressing is appropriate for use on the…
Read the full statement (114 words)
Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.
A4-XLR8 Foam Dressing 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 flap and grafts
Caution: Federal 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/K092992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092992: A4-XLR8 Foam Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092992
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