510(k) · Cleared
ClearedMedela Dominant 50 Lipo, Model 600-5706
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medela AG · QPB System, Suction, Lipoplasty For Removal
Cleared on Feb 26, 2007 as substantially equivalent to K021368 (Medela AG, 2002) and 2 other predicates after a 112-day review. Its family tree reaches back 5 generations to 1989. 4 later devices descend from it.
- Decided
- Feb 26, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K895761 (1989). 11 ancestors in all, the oldest K832274 (1983). 4 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK895761 General AsperatorKolster Methods · 1989
- 4 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 3 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 2 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 1 generation backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- This deviceK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
- Descendant · cites it directly · 2 of its ownK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
- 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
- Descendant · cites it directly · 0 of its ownK082025 Body-JetHuman Med AG · 2008 · Recalled
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −4 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −3 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −2 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −1 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| 0 (this device) | K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | 2007 | — |
| +1 | K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015 | — |
| +2 | K160950 | Miniscav | Sedation Systems, LLC | 2017 | 1 |
| +2 | K170329 | Basic, Dominant Flex | Modela AG | 2017 | 1 |
| +1 | K082025 | Body-Jet | Human Med AG | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 QPB? 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 QPB device
- #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 5…tion 878.5040 Product Code: MUU 3 Name of the predicate Device(s) * Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K021368 * HK Liposuction Aspirator, Model AP-III & AP230-111, by HK Surgical Inc. K032802 * Vacusat® (Aspiration/Suction Pu… | 2002 |
| * | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-IiiSummary page 5…Medela® Basic, Median, Dominant, Vario Suction Pumps, by Medela Inc. K021368 * HK Liposuction Aspirator, Model AP-III & AP230-111, by HK Surgical Inc. K032802 * Vacusat® (Aspiration/Suction Pump), Model # 00 002 252 and Model # 00 002 318, by Moeller Medical GmbH & Co. AG… | 2003 |
| * | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Summary page 5…-111, by HK Surgical Inc. K032802 * Vacusat® (Aspiration/Suction Pump), Model # 00 002 252 and Model # 00 002 318, by Moeller Medical GmbH & Co. AG K053451 E_510k Summary_D50_Lipo.doc 2006-11-02 Section E -1 of 3 Applicant:… | 2006 |
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?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K150134 (Medela AG, 2015) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K021368.
How does its category compare?
All QPB devicesQPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · QPB
5so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QPB
194in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QPB
No recall names QPB since 2007.
Adverse event reports per year · QPB
16in 2025
MAUDE reports naming product code QPB, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 69 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 3 | 234 | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 112 | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 4 | 194 | 0 | 16 |
| 2025 | 2 | — | 0 | 16 |
| 2026 | 5 | 238 | 0 | — |
What is it indicated for?
The Medela® Dominant 50 Lipo is intended to be used for aesthetic body contouring.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K063336 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063336: Medela Dominant 50 Lipo, Model 600-5706.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063336
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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