510(k) · Cleared
ClearedBasic, Median, Dominant, and Vario
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela, Inc. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jan 7, 1999 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 188 devices in its family, counting itself, has a Class I recall. 187 later devices descend from it.
- Decided
- Jan 7, 1999
- Review
- 90 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 0
187 later devices descend from it, 9 citing it directly. 1 of the 188 devices in this family, counting this one, has a Class I recall.
- This deviceK983552 Basic, Median, Dominant, and VarioMedela, Inc. · 1999
- Descendant · cites it directly · 159 of its ownK042134 Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · Recalled
- Descendant · 2 generations on · 127 of its ownK052456 Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005
- Descendant · cites it directly · 120 of its ownK061435 Medela Vario Suction PumpsMedela AG · 2006
- Descendant · 2 generations on · 109 of its ownK070904 Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007
- Descendant · 2 generations on · 107 of its ownK061919 Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · Recalled
Showing 5 of 187 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K093261 MOVES2 generations on · 2010
Most influential descendants
Showing 5 of 187 · See all- K042134Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2004 · cites it directly159descendants
- K052456Modification to Versatile 1 Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2005 · 2 generations on127descendants
- K061435Medela Vario Suction PumpsMedela AG · 2006 · cites it directly120descendants
- K070904Antlia II Suction Pump SystemInnovative Therapies, Inc. · 2007 · 2 generations on109descendants
- K061919Versatile 1 Ezcare Wound Vacuum SystemBlue Sky Medical Group Incorporated · 2007 · 2 generations on107descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983552 | Basic, Median, Dominant, and Vario | Medela, Inc. | 1999 | — |
| +1 | K042134 | Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2004 | 2 |
| +2 | K052456 | Modification to Versatile 1 Wound Vacuum System | Blue Sky Medical Group Incorporated | 2005 | — |
| +1 | K061435 | Medela Vario Suction Pumps | Medela AG | 2006 | — |
| +2 | K070904 | Antlia II Suction Pump System | Innovative Therapies, Inc. | 2007 | — |
| +2 | K061919 | Versatile 1 Ezcare Wound Vacuum System | Blue Sky Medical Group Incorporated | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 9 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 1 |
| 2011 | 7 | 0 |
| 2012 | 8 | 0 |
| 2013 | 8 | 0 |
| 2014 | 16 | 0 |
| 2015 | 16 | 0 |
| 2016 | 18 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 12 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 6 | 0 |
| 2026 | 6 | 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.
1 device in this family has a Class I recall. 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? (187)
See all 1879 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042134 | Versatile 1 Wound Vacuum System | 2004 | 159 |
| K061435 | Medela Vario Suction Pumps | 2006 | 120 |
| K061205 | Medela Vario 8/18/CI Secretion & Surgical Aspirator | 2006 | 85 |
| K060277 | Boehringer Laboratories Suction Pump System | 2006 | 45 |
| K061133 | Simex Suction Pump, Models AC20, AC20K, AC30, DC20, DC30 and DC30S | 2006 | 18 |
| K060963 | Twin Star Compartment Pressure Monitoring and Fluid Collection Monitor (CMS Monitor) | 2006 | 9 |
| K082311 | Exsudex Wound Drainage Pump | 2008 | 0 |
| K033179 | Medela Clario Home Care Pump | 2003 | 0 |
| K011601 | Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX | 2001 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K093261MOVESThornhill Research, Inc. · 2010 · 2 generations on · ◆ in the 2010 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K042134 (Blue Sky Medical Group Incorporated, 2004) has gone furthest, with 159 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, Median, Dominant and Vario 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/K983552 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983552: Basic, Median, Dominant, and Vario.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983552
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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