510(k) · Cleared
ClearedVenturi Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Talley Medical · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jul 15, 2008 as substantially equivalent to K042134 (Blue Sky Medical Group Incorporated, 2004) and 2 other predicates after a 106-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it.
- Decided
- Jul 15, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K945062 (1995). 6 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 2 generations backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- 1 generation backK061788 Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 2006 · Recalled
- This deviceK080897 Venturi Negative Pressure Wound Therapy SystemTalley Medical · 2008
- Descendant · cites it directly · 1 of its ownK151263 Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK161948 Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016
- Descendant · cites it directly · 0 of its ownK161797 Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC · 2016
- Descendant · cites it directly · 0 of its ownK143004 VENTURI MiNO TG600/14Talley Group, Ltd. · 2016
Most influential descendants
Showing 4 of 4 · See all- K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd. · 2016 · cites it directly1descendant
- K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016 · 2 generations on0descendants
- K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC · 2016 · cites it directly0descendants
- K143004VENTURI MiNO TG600/14Talley Group, Ltd. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −2 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| −1 | K061788 | Boehringer Laboratories Suction Pump System | Boehringer Laboratories | 2006 | 5 |
| 0 (this device) | K080897 | Venturi Negative Pressure Wound Therapy System | Talley Medical | 2008 | — |
| +1 | K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | 2016 | — |
| +2 | K161948 | Avance Gauze Dressing Kits | Molnlycke Health Care Us, LLC | 2016 | — |
| +1 | K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | Molnlycke Health Care Us, LLC | 2016 | — |
| +1 | K143004 | VENTURI MiNO TG600/14 | Talley Group, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…ion 878.4780 Classification Panel: General and Plastic Surgery Predicate Devices: Blue Sky Versatile 1 System K042134, KO52456 Boehringer Labs Suction Pump system K061788 Device Description: The Talley VenturiTM sy… | 2004 |
| * | K052456 | Modification to Versatile 1 Wound Vacuum System | 2005 |
| * | K061788 | Boehringer Laboratories Suction Pump SystemSummary page 1…c Surgery Predicate Devices: Blue Sky Versatile 1 System K042134, KO52456 Boehringer Labs Suction Pump system K061788 Device Description: The Talley VenturiTM system consists of a powered suction pump for the application of vacuum to wounds for fl… | 2006 |
What descends from it? (4)
3 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 13 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K151263 (Talley Group, Ltd., 2016) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K042134.
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. 2008, 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?
Use of the VenturjTM Negative Pressure Wound Therapy system is indicated for use for patients with acute or chronic wounds that may be benefited by the application of negative pressure therapy and the potential wound healing effects of removal of fluids induding wound exudates, irrigation flUids, body fluids, and infectious materials. Venturi is intended for use in acute care settings only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080897 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080897: Venturi Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080897
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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