510(k) · Cleared
Recalled · 2008Versatile 1 Wound Vacuum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Blue Sky Medical Group Incorporated · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Nov 1, 2004 as substantially equivalent to K945062 (Kinetic Concepts, Inc., 1995) and 1 other predicate after an 84-day review. Its family tree reaches back 1 generation to 1995. 1 of the 162 devices in its family, counting itself, has a Class I recall. 159 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 1, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K945062 (1995). 2 ancestors in all. 159 later devices descend from it, 10 citing it directly. 1 of the 162 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK945062 VacplusKinetic Concepts, Inc. · 1995
- This deviceK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004
- Descendant · cites it directly · 127 of its ownK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- Descendant · cites it directly · 120 of its ownK061435 Medela Vario Suction PumpsMedela AG · 2006
- Descendant · 2 generations on · 109 of its ownK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- Descendant · cites it directly · 107 of its ownK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
- Descendant · 2 generations on · 68 of its ownK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
Showing 5 of 159 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVES2 generations on · 2010
Most influential descendants
Showing 5 of 159 · See all- K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005 · cites it directly127descendants
- K061435Medela Vario Suction PumpsMedela AG · 2006 · cites it directly120descendants
- K070904Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007 · 2 generations on109descendants
- K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · cites it directly107descendants
- K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · 2 generations on68descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| 0 (this device) | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | — |
| +1 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| +1 | K061435 | Medela Vario Suction Pumps | Medela AG | 2006 | — |
| +2 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| +1 | 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 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 6 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 1 |
| 2011 | 6 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 12 | 0 |
| 2015 | 15 | 0 |
| 2016 | 18 | 0 |
| 2017 | 11 | 0 |
| 2018 | 11 | 0 |
| 2019 | 12 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 9 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 5 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K945062 | VacplusSummary page 4…nage Device) (VI WVS) II. Classification Name: Powered suction Pump (per 21 CFR 878.4780) III. Substantial Equivalence V.A.C.® Plus 510(k) No. 945062 Medela Vario 510(k) 983552 IV. Device Description The BlueSky Versatile 1 WVS is a… | 1995 |
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 4…: Powered suction Pump (per 21 CFR 878.4780) III. Substantial Equivalence V.A.C.® Plus 510(k) No. 945062 Medela Vario 510(k) 983552 IV. Device Description The BlueSky Versatile 1 WVS is a portable suction device that can be powered by an internal batter… | 1999 |
What descends from it? (159)
See all 15910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052456 | Modification to Versatile 1 Wound Vacuum System | 2005 | 127 |
| K061435 | Medela Vario Suction Pumps | 2006 | 120 |
| K061919 | Versatile 1 Ezcare Wound Vacuum System | 2007 | 107 |
| K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound… | 2011 | 48 |
| K061367 | Bluesky Vista Wound Vacuum System, Model 100.0500 | 2006 | 24 |
| K062456 | Novaspine Powered Suction Pump Pro-1 | 2006 | 16 |
| K050129 | Celleration Mist Therapy System 5.1 | 2005 | 6 |
| K061788 | Boehringer Laboratories Suction Pump System | 2006 | 5 |
| K113291 | Simex Negative Pressure Wound Therapy Powered Suction Pumps Series: Sim-EX200 and… | 2012 | 4 |
| K080897 | Venturi Negative Pressure Wound Therapy System | 2008 | 4 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 7, 2008 | Not classified | Z-0162-2009 | Nonconforming Material/Component | External battery chargers used with the Version 29 VISTA Negative Pressure Wound Therapy pumps are failing to properly charge the pump's battery. |
| Mar 31, 2008 | Not classified | Z-1620-2008 | Labeling mix-ups | Incorrect labeling. Kit labels may incorrectly state that a flat drain is contained as a kit component while some kits may contain a round drain. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
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 Versatile 1 Wound Vacuum System is indicated for patients who would
benefit from a suction device particularly as the device may promote wound
healing or for aspiration and removal of surgical fluids, tissue (including bone),
gases, bodily fluids, or infectious materials from a patients airway or respiratory
support system either during surgery or at the patients bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042134: Versatile 1 Wound Vacuum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042134
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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