510(k) · Cleared
ClearedEnivo™
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aroa Biosurgery, Ltd. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Apr 7, 2023 as substantially equivalent to K222856 (Somavac Medical Solutions, Inc., 2022) after a 154-day review. Its family tree reaches back 4 generations to 1988.
- Decided
- Apr 7, 2023
- Review
- 154 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 deviceK223373 Enivo™Aroa Biosurgery, Ltd. · 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) | K223373 | Enivo™ | Aroa Biosurgery, Ltd. | 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…ber 878.4780 Product Code BTA | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K222856 SOMAVAC Device BTA Device Description Summary 21 CFR 807.92(a)(4) Enivo™is a surgical drainage system intended for the removal o… | 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 4 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?
Enivo™ is indicated for use to remove surgical and bodily fluids from a closed wound for hematoma and seroma prophylaxis following plastic surgery or other general surgeries where large flaps are formed.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223373 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223373: Enivo™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223373
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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