510(k) · Cleared
ClearedNPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Creo Quality, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on May 2, 2014 as substantially equivalent to K082676 (Genadyne Biotechnologies, Inc., 2008) and 1 other predicate after a 305-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- May 2, 2014
- Review
- 305 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945062 (1995). 11 ancestors in all. 1 later device descends 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 deviceK132004 NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- LargeCreo Quality, LLC · 2014
- Descendant · cites it directly · 0 of its ownK182458 Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182458Longterm NPWT Foam Dressing KitZhejiang Longterm Medical Technology Co., Ltd. · 2019 · cites it directly0descendants
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) | K132004 | NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large | Creo Quality, LLC | 2014 | — |
| +1 | K182458 | Longterm NPWT Foam Dressing Kit | Zhejiang Longterm Medical Technology Co., Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K082676 | Genadyne A4 Wound Vacuum SystemSummary page 1…Brand Name 510(k) Number Genadyne A4 Wound Dressing Vacuum System Kit K082676 Biotech nologies, Inc. Genadyne A4-XLR8 Foam Dressing K092992… | 2008 |
| * | K092992 | A4-XLR8 Foam DressingSummary page 1…ng Vacuum System Kit K082676 Biotech nologies, Inc. Genadyne A4-XLR8 Foam Dressing K092992 Biotechnologies, Inc. ________________________ ________ DEVICE DESCRIPTION… | 2010 |
| † | K951842 | Bioderm Medical Transparent Film Dressing | 1995 |
| † | K990955 | Modification of:Bioderm Foam Wound Dressing | 1999 |
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 |
|---|---|---|---|
| K182458 | Longterm NPWT Foam Dressing Kit | 2019 | 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 19 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K182458 (Zhejiang Longterm Medical Technology Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K082676.
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. 2014, 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?
Cork Medical Products NPWT Wound Dressing Kit is intended to be used in conjunction with the Genadyne XLR8 Pump to deliver negative pressure wound therapy to the wound.
When used in conjunction with a NPWT pump system, Cork Medical Products NPWT Wound Dressing Kit 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132004 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132004: NPWT Wound Dressing Kit- Medium, NPWT Wound Dressing Kit- Large.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132004
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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