510(k) · Cleared
ClearedVaridyne Model 250 Suction Drainage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgidyne, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Oct 3, 1988 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Oct 3, 1988
- Review
- 42 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK883582 Varidyne Model 250 Suction Drainage SystemSurgidyne, Inc. · 1988
- Descendant · cites it directly · 4 of its ownK972703 Redyrob-Closed Wound Drainage SystemB.Braun Medical, Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK180606 SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018
- Descendant · 3 generations on · 2 of its ownK222856 SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK231063 SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023
- Descendant · 4 generations on · 0 of its ownK223373 Enivo™Aroa Biosurgery, Ltd. · 2023
Most influential descendants
Showing 5 of 5 · See all- K972703Redyrob-Closed Wound Drainage SystemB.Braun Medical, Inc. · 1997 · cites it directly4descendants
- K180606SOMAVAC DeviceSomavac Medical Solutions, Inc. · 2018 · 2 generations on3descendants
- K222856SOMAVAC 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2022 · 3 generations on2descendants
- K231063SOMAVAC® 100 Sustained Vacuum SystemSomavac Medical Solutions, Inc. · 2023 · 4 generations on0descendants
- K223373Enivo™Aroa Biosurgery, Ltd. · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883582 | Varidyne Model 250 Suction Drainage System | Surgidyne, Inc. | 1988 | — |
| +1 | K972703 | Redyrob-Closed Wound Drainage System | B.Braun Medical, Inc. | 1997 | — |
| +2 | K180606 | SOMAVAC Device | Somavac Medical Solutions, Inc. | 2018 | — |
| +3 | K222856 | SOMAVAC 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2022 | — |
| +4 | K231063 | SOMAVAC® 100 Sustained Vacuum System | Somavac Medical Solutions, Inc. | 2023 | — |
| +4 | K223373 | Enivo™ | Aroa Biosurgery, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K972703 | Redyrob-Closed Wound Drainage System | 1997 | 4 |
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?
- Of its descendants, K972703 (B.Braun Medical, Inc., 1997) has gone furthest, with 4 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K883582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K883582: Varidyne Model 250 Suction Drainage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K883582
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026