510(k) · Cleared
ClearedMedela Vario Suction Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jun 8, 2006 as substantially equivalent to K983552 (Medela, Inc., 1999) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1995. 1 of the 124 devices in its family, counting itself, has a Class I recall. 120 later devices descend from it.
- Decided
- Jun 8, 2006
- Review
- 15 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K945062 (1995). 3 ancestors in all. 120 later devices descend from it, 3 citing it directly. 1 of the 124 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 1 generation backK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- This deviceK061435 Medela Vario Suction PumpsMedela AG · 2006
- Descendant · cites it directly · 109 of its ownK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- Descendant · 2 generations on · 68 of its ownK082211 Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 48 of its ownK110647 Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys…Smith & Nephew, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 31 of its ownK092992 A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010
Showing 5 of 120 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVEScites it directly · 2010
Most influential descendants
Showing 5 of 120 · See all- K070904Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007 · cites it directly109descendants
- K082211Renasys-F Negative Pressure Wound Therapy Foam Dressing KitsSmith & Nephew, Inc. · 2008 · 2 generations on68descendants
- K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 2 generations on56descendants
- K110647Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT Wound…Smith & Nephew, Inc. · 2011 · 3 generations on48descendants
- K092992A4-XLR8 Foam DressingGenadyne Biotechnologies, Inc. · 2010 · 3 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −1 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| 0 (this device) | K061435 | Medela Vario Suction Pumps | Medela AG | 2006 | — |
| +1 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| +2 | K082211 | Renasys-F Negative Pressure Wound Therapy Foam Dressing Kits | Smith & Nephew, Inc. | 2008 | 1 |
| +2 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| +3 | K110647 | Renasys Foam NPWT Wound Dressing Kits with Suction Pad; Renasys Gauze NPWT… | Smith & Nephew, Inc. | 2011 | 6 |
| +3 | K092992 | A4-XLR8 Foam Dressing | Genadyne Biotechnologies, Inc. | 2010 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 1 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 9 | 0 |
| 2015 | 13 | 0 |
| 2016 | 14 | 0 |
| 2017 | 11 | 0 |
| 2018 | 8 | 0 |
| 2019 | 11 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 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 |
|---|---|---|---|
| * | K983552 | Basic, Median, Dominant, and VarioSummary page 1…CFR 878.4780 Product Code: BTA 3 Name of the predicate Device(s) * Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K983552 * Versatile 1 Wound Vacuum System, by Blue Sky Medical Group Incorporated K042134 E_510k_Summary Varo.doc… | 1999 |
| * | K042134 | Versatile 1 Wound Vacuum SystemSummary page 1…Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K983552 * Versatile 1 Wound Vacuum System, by Blue Sky Medical Group Incorporated K042134 E_510k_Summary Varo.doc 2006-02-16 Section E - 1 of 4 Applicant:… | 2004 |
What descends from it? (120)
See all 1203 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K070904 (Innovative Therapies, Inc., 2007) has gone furthest, with 109 descendants of its own.
- 8 other devices also cite its predicate K983552.
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 Medela Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's air-way or respiratory support system, either during surgery or at the patient's bedside. The Medela Vario 18 cli Suction Pump is indicated for patients who would benefit from a suctior device particularly as the device may promote wound healing. The…
Read the full statement (110 words)
The Medela Vario 8 and 18 Suction Pumps are indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's air-way or respiratory support system, either during surgery or at the patient's bedside.
The Medela Vario 18 cli Suction Pump is indicated for patients who would benefit from a suctior device particularly as the device may promote wound healing. The device is also indicated for aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids (includin~ vomit) or infectious materials from a patient's airway or respiratory support system, either during surgery or at the patient's bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061435 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061435: Medela Vario Suction Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061435
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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