510(k) · Cleared
Recalled · Class II · 2020Basic, Dominant Flex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Modela AG · QPB System, Suction, Lipoplasty For Removal
Cleared on Mar 24, 2017 as substantially equivalent to K150134 (Medela AG, 2015) and 1 other predicate after a 50-day review. Its family tree reaches back 7 generations to 1989. It has been recalled once.
- Decided
- Mar 24, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- QPB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K895761 (1989). 21 ancestors in all, the oldest K832274 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK895761 General AsperatorKolster Methods · 1989
- 6 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 5 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 4 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 3 generations backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- 2 generations backK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
- 1 generation backK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
- This deviceK170329 Basic, Dominant FlexModela AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −6 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −5 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −4 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −3 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| −2 | K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | 2007 | — |
| −1 | K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015 | — |
| 0 (this device) | K170329 | Basic, Dominant Flex | Modela AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2013 | 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 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? (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 |
|---|---|---|---|
| * | K150134 | Basic, Dominant Flex, KV-6Summary page 7…K170329 Page 2 of 4 PREDICATE DEVICE(S): K150134 Basic and Dominant Flex Suction Pumps K051758 Penumbra Aspiration Pump DEVICE DESCRIPTION: The Medela® Basic and Dominant Flex… | 2015 |
| * | K051758 | Penumbra Aspiration Pump, Model 115VSummary page 7…329 Page 2 of 4 PREDICATE DEVICE(S): K150134 Basic and Dominant Flex Suction Pumps K051758 Penumbra Aspiration Pump DEVICE DESCRIPTION: The Medela® Basic and Dominant Flex are high vacuum and high flow, AC-powered suct… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 2, 2020 | Class II | Z-1502-2021 | Process control | Incorrect expiration date of "2023-07-24" on label of sterile tubing. Correct expiration date should be "2021-07-24". |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 6 companies; a new generation was cleared every 2.8 years on median.
- None of the 21 ancestors has a recall.
- 1 other device also cites its predicate K150134.
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. 2017, 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 intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics. This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during…
Read the full statement (146 words)
The intended use of the Dominant Flex suction pump is the creation of a constant vacuum for use in hospitals and clinics.
This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aesthetic body contouring, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass, and epicardial ablation probes.
The intended use of the Basic suction pump is the creation of a constant vacuum for use in hospitals and clinics.
This vacuum can be used for general suction, to aspirate and remove: surgical fluids, tissue (including bone), gases, bodily fluids or infectious materials and during specific procedures which may include, vacuum extraction, aspiration during flexible endoscopy, use with cardiac tissue stabilizers during off-pump coronary artery bypass and epicardial ablation probes.
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/K170329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170329: Basic, Dominant Flex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170329
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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