510(k) · Cleared
ClearedVenturi Gauze Wound Care Sets with Portal Drain
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talley Group, Ltd. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Feb 19, 2016 as substantially equivalent to K080897 (Talley Medical, 2008) and 1 other predicate after a 282-day review. Its family tree reaches back 7 generations to 1995. 1 later device descends from it.
- Decided
- Feb 19, 2016
- Review
- 282 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K945062 (1995). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 6 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 5 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 4 generations backK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- 3 generations backK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- 2 generations backK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- 1 generation backK122132 Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad…Molnlycke Health Care · 2013
- This deviceK151263 Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK161948 Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016
Most influential descendants
Showing 1 of 1 · See all- K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −6 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −5 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −4 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
| −3 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| −2 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| −1 | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium… | Molnlycke Health Care | 2013 | — |
| 0 (this device) | K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | 2016 | — |
| +1 | K161948 | Avance Gauze Dressing Kits | Molnlycke Health Care Us, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K080897 | Venturi Negative Pressure Wound Therapy SystemSummary page 4…Venturi™ NPWT v.II 21 CFR 878.4780; Talley Group Advanced Vacuum K080897 OMP System Mölnlycke Health Care Avance® Foam… | 2008 |
| * | K122132 | Avance Foam Dressing Kit Incl. Transparent Film, Transfer Pad (Small, Medium, Large)…Summary page 4…OMP System Mölnlycke Health Care Avance® Foam 21 CFR 878.4780; K122132 US, LLC Dressing Kits OMP Issue 3 © Talley Group Ltd… | 2013 |
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 |
|---|---|---|---|
| K161948 | Avance Gauze Dressing Kits | 2016 | 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 21 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K161948 (Molnlycke Health Care Us, LLC, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K080897.
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. 2016, 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?
Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified…
Read the full statement (116 words)
Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.
NPWT is contraindicated for patients with:
1. Malignancy in the wound
2. Untreated osteomyelitis
3. Non-enteric and unexplored fistulas
4. Wounds with difficult haemostasis
5. Necrotic tissue with eschar present
6. Exposed vasculature, bone, nerves, or organs
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151263: Venturi Gauze Wound Care Sets with Portal Drain.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151263
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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