510(k) · Cleared
ClearedBasic and Dominant Flex Suction Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Oct 11, 2013 as substantially equivalent to K021368 (Medela AG, 2002) and 1 other predicate after a 267-day review. Its family tree reaches back 1 generation to 2001. 4 later devices descend from it.
- Decided
- Oct 11, 2013
- Review
- 267 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011725 (2001). 2 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK011725 Olympus Suction Pump, Model KV-5Keymed (Medical & Industrial Equipment), Ltd. · 2001
- This deviceK130123 Basic and Dominant Flex Suction PumpsMedela AG · 2013
- Descendant · cites it directly · 2 of its ownK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
- Descendant · cites it directly · 0 of its ownK260892 Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK160950 MiniscavSedation Systems, LLC · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK170329 Basic, Dominant FlexModela AG · 2017 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K150134Basic, Dominant Flex, KV-6Medela AG · 2015 · cites it directly2descendants
- K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd. · 2026 · cites it directly0descendants
- K160950MiniscavSedation Systems, LLC · 2017 · 2 generations on0descendants
- K170329Basic, Dominant FlexModela AG · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011725 | Olympus Suction Pump, Model KV-5 | Keymed (Medical & Industrial Equipment), Ltd. | 2001 | — |
| 0 (this device) | K130123 | Basic and Dominant Flex Suction Pumps | Medela AG | 2013 | — |
| +1 | K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015 | — |
| +1 | K260892 | Suction Pump (SU-90) | Shenzhen HugeMed Medical Technical Development Co., Ltd. | 2026 | — |
| +2 | K160950 | Miniscav | Sedation Systems, LLC | 2017 | 1 |
| +2 | K170329 | Basic, Dominant Flex | Modela AG | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Summary page 3…Basic and Dominant Flex Basic 30 and Dominant 50 Discussion of Differences 510(k) -- K021368 Number Indications The Basic and Dominant The Basic 30 and Equivalent. Dominant 50 for Use… | 2002 |
| * | K011725 | Olympus Suction Pump, Model KV-5Summary page 3…exratinasirtin vacuum extraction, Olympus Ky-S Suction extrain , aspxi ratio aspiration and removal of Pump (K011725) is durn g flexiblen surgical fluids, tissue cleared for the indication… | 2001 |
| † | K042943 | Nouvag AG - Vacuson 40 and Vacuson 60 | 2004 |
| † | K993668 | Laerdal Suction Unit,(4000) Model 78 00 20 | 1999 |
What descends from it? (4)
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. 2013, 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 Basic and Dominant Flex Suction Pumps are indicated for vacuum extraction, aspiration during flexible endoscopy and aspiration and removal of surgical fluids, tissue (including bone), gases, bodily fluids or Infectious materials from wounds or from a patient's airway or respiratory support system either during surgery or at the bedside.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130123 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130123: Basic and Dominant Flex Suction Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130123
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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