510(k) · Cleared
ClearedNouvag AG - Vacuson 40 and Vacuson 60
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nouvag AG · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Dec 17, 2004 as substantially equivalent to K021368 (Medela AG, 2002) after a 53-day review. Its family tree reaches back 1 generation to 2002. 2 later devices descend from it.
- Decided
- Dec 17, 2004
- Review
- 53 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021368 (2002). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK021368 Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Medela AG · 2002
- This deviceK042943 Nouvag AG - Vacuson 40 and Vacuson 60Nouvag AG · 2004
- Descendant · cites it directly · 0 of its ownK092903 Bora UP 2080, Bora UP 2080 OP and Bora UP 2080 MountingMaquet GmbH and Co. KG · 2009
- Descendant · cites it directly · 0 of its ownK090445 Atmos C361/C451 Suction PumpAtmos, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 | Medela AG | 2002 | — |
| 0 (this device) | K042943 | Nouvag AG - Vacuson 40 and Vacuson 60 | Nouvag AG | 2004 | — |
| +1 | K092903 | Bora UP 2080, Bora UP 2080 OP and Bora UP 2080 Mounting | Maquet GmbH and Co. KG | 2009 | — |
| +1 | K090445 | Atmos C361/C451 Suction Pump | Atmos, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Summary page 1…-ate-d-evilce or 1eallv marketed device or devices to which substantial eciialne sbin lamd Medela AG Medela "Basic 30" and "Dominant 50" Suction Pumps K021368, Cleared on 05/15/2002 5-1 NOUVAG AG… | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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 | — |
What is it indicated for?
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042943 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042943: Nouvag AG - Vacuson 40 and Vacuson 60.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042943
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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