510(k) · Cleared
Recalled · 2010Boehringer Laboratories Suction Pump System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Laboratories · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jul 11, 2006 as substantially equivalent to K060277 (Boehringer Laboratories, 2006) and 2 other predicates after a 15-day review. Its family tree reaches back 3 generations to 1995. 5 later devices descend from it. It has been recalled 5 times.
- Decided
- Jul 11, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 3 generations to K945062 (1995). 5 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- 1 generation backK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- This deviceK061788 Boehringer Laboratories Suction Pump SystemBoehringer Laboratories · 2006
- Descendant · cites it directly · 4 of its ownK080897 Venturi Negative Pressure Wound Therapy SystemTalley Medical · 2008
- Descendant · 2 generations on · 1 of its ownK151263 Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd. · 2016
- Descendant · 3 generations on · 0 of its ownK161948 Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK161797 Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK143004 VENTURI MiNO TG600/14Talley Group, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical · 2008 · cites it directly4descendants
- K151263Venturi Gauze Wound Care Sets with Portal DrainTalley Group, Ltd. · 2016 · 2 generations on1descendant
- K161948Avance Gauze Dressing KitsMolnlycke Health Care Us, LLC · 2016 · 3 generations on0descendants
- K161797Avance Tubing, Avance Y-Connector, Avance ViewPadMolnlycke Health Care Us, LLC · 2016 · 2 generations on0descendants
- K143004VENTURI MiNO TG600/14Talley Group, Ltd. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| −1 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| 0 (this device) | K061788 | Boehringer Laboratories Suction Pump System | Boehringer Laboratories | 2006 | — |
| +1 | K080897 | Venturi Negative Pressure Wound Therapy System | Talley Medical | 2008 | — |
| +2 | K151263 | Venturi Gauze Wound Care Sets with Portal Drain | Talley Group, Ltd. | 2016 | — |
| +3 | K161948 | Avance Gauze Dressing Kits | Molnlycke Health Care Us, LLC | 2016 | — |
| +2 | K161797 | Avance Tubing, Avance Y-Connector, Avance ViewPad | Molnlycke Health Care Us, LLC | 2016 | — |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K060277 | Boehringer Laboratories Suction Pump SystemSummary page 1…duct Code: JCX Regulation 878.4780 Classification Panel: Genera? & Plastic Surgery Predicate Devices: Boehringer Laboratories Suction Pump System K060277 Versatile 1 Wound Vacuum System K042134, K052456 Device Description: The Boehringer Laboratori… | 2006 |
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…Surgery Predicate Devices: Boehringer Laboratories Suction Pump System K060277 Versatile 1 Wound Vacuum System K042134, K052456 Device Description: The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the applicat… | 2004 |
| * | K052456 | Modification to Versatile 1 Wound Vacuum SystemSummary page 1…Predicate Devices: Boehringer Laboratories Suction Pump System K060277 Versatile 1 Wound Vacuum System K042134, K052456 Device Description: The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of su… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080897 | Venturi Negative Pressure Wound Therapy System | 2008 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2010 | Not classified | Z-2609-2010 | Device Design | Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity. |
| Jul 29, 2009 | Not classified | Z-2044-2009 | Labeling design | Labeling: The expiration date does not appear on the product label. |
| Jul 29, 2009 | Not classified | Z-2043-2009 | Labeling design | Labeling: The expiration date does not appear on the product label. |
| Jul 29, 2009 | Not classified | Z-2045-2009 | Labeling design | Labeling: The expiration date does not appear on the product label. |
| Jul 13, 2009 | Not classified | Z-1814-2009 | Labeling Change Control | Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K080897 (Talley Medical, 2008) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K060277.
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.
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?
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation flUids, body fluids and infectious materials.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061788: Boehringer Laboratories Suction Pump System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061788
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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