510(k) · Cleared
ClearedMedela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057
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 May 15, 2002 after a 15-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 119 later devices descend from it.
- Decided
- May 15, 2002
- Review
- 15 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
119 later devices descend from it, 8 citing it directly.
- This deviceK021368 Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057Medela AG · 2002
- Descendant · cites it directly · 93 of its ownK043544 Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005
- Descendant · 2 generations on · 85 of its ownK061205 Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · Recalled
- Descendant · 3 generations on · 75 of its ownK080357 Medela Invia Wound TherapyMedela AG · 2008 · Recalled
- Descendant · 4 generations on · 56 of its ownK083375 Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · Recalled
- Descendant · 5 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
Showing 5 of 119 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 119 · See all- K043544Medela Dominant 35 C/I Secretion and Surgical AspiratorMedela AG · 2005 · cites it directly93descendants
- K061205Medela Vario 8/18/CI Secretion & Surgical AspiratorMedela AG · 2006 · 2 generations on85descendants
- K080357Medela Invia Wound TherapyMedela AG · 2008 · 3 generations on75descendants
- K083375Renasys GO Negative Pressure Wound TherapySmith & Nephew, Inc. · 2009 · 4 generations on56descendants
- K111170PICOSmith & Nephew, Inc. · 2011 · 5 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021368 | Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057 | Medela AG | 2002 | — |
| +1 | K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | Medela AG | 2005 | — |
| +2 | K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | Medela AG | 2006 | 1 |
| +3 | K080357 | Medela Invia Wound Therapy | Medela AG | 2008 | 1 |
| +4 | K083375 | Renasys GO Negative Pressure Wound Therapy | Smith & Nephew, Inc. | 2009 | 2 |
| +5 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 12 | 0 |
| 2017 | 10 | 0 |
| 2018 | 12 | 0 |
| 2019 | 8 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 9 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (119)
See all 1198 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043544 | Medela Dominant 35 C/I Secretion and Surgical Aspirator | 2005 | 93 |
| K072870 | Microwave Tissue Coagulation System (MTCS) | 2008 | 11 |
| K100624 | Invendo C20 Colonoscopy System | 2012 | 6 |
| K130123 | Basic and Dominant Flex Suction Pumps | 2013 | 4 |
| K063336 | Medela Dominant 50 Lipo, Model 600-5706 | 2007 | 4 |
| K042943 | Nouvag AG - Vacuson 40 and Vacuson 60 | 2004 | 2 |
| K052626 | Smartsuction Harmony Device | 2005 | 1 |
| K041405 | Aspiration Pump, Model Imd-020 | 2004 | 0 |
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, K043544 (Medela AG, 2005) has gone furthest, with 93 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 | — |
What is it indicated for?
The Basic 30 and Dominant 50 Suction Pumps are indicated for vacuum extraction, 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 patient's bedside.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021368 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021368: Medela Basic 30 and Dominant 50 Suction Pumps, Models 037, 057.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021368
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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