510(k) · Cleared
ClearedSOMAVAC® 100 Sustained Vacuum System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Somavac Medical Solutions, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on May 12, 2023 as substantially equivalent to K222856 (Somavac Medical Solutions, Inc., 2022) after a 28-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- May 12, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K883582 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK883582 Varidyne Model 250 Suction Drainage SystemSurgidyne, Inc. · 1988
- 3 generations backK972703 Redyrob-Closed Wound Drainage SystemB.Braun Medical, Inc. · 1997
- 2 generations backK180606 SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018
- 1 generation backK222856 SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022
- This deviceK231063 SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K883582 | Varidyne Model 250 Suction Drainage System | Surgidyne, Inc. | 1988 | — |
| −3 | K972703 | Redyrob-Closed Wound Drainage System | B.Braun Medical, Inc. | 1997 | — |
| −2 | K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | 2018 | — |
| −1 | K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2022 | — |
| 0 (this device) | K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2014 | 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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K222856 | SOMAVAC 100 Sustained Vacuum SystemSummary page 4…assification: Class II Regulation Number: 21 CFR 878.4780 Panel: General and Plastic Surgery Product Code: BTA Primary Predicate: SOMAVAC® 100 (K222856), Manufacturer: SOMAVAC Medical Solutions, Inc. SOMAVAC® 100 Sustained Vacuum System (SOMAVA… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 1 other device also cites its predicate K222856.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
The SOMAVAC® 100 Sustained Vacuum System (SOMAVAC® 100) is a portable battery powered vacuum source / waste container intended for the removal of surgical and bodily fluids from a closed wound following plastic surgery and other general surgery forming large flaps for hematoma and seroma prophylaxis. It is intended for use in homecare and healthcare environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231063 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231063: SOMAVAC® 100 Sustained Vacuum System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231063
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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