510(k) · Cleared
ClearedBasic, Dominant Flex, KV-6
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 Apr 21, 2015 as substantially equivalent to K130123 (Medela AG, 2013) and 2 other predicates after a 90-day review. Its family tree reaches back 6 generations to 1989. 2 later devices descend from it.
- Decided
- Apr 21, 2015
- Review
- 90 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K895761 (1989). 19 ancestors in all, the oldest K832274 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK895761 General AsperatorKolster Methods · 1989
- 5 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
- 4 generations backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- 3 generations backK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- 2 generations backK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- 1 generation backK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
- This deviceK150134 Basic, Dominant Flex, KV-6Medela AG · 2015
- Descendant · cites it directly · 0 of its ownK160950 MiniscavSedation Systems, LLC · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK170329 Basic, Dominant FlexModela AG · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −5 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| −4 | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| −3 | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | Hk Surgical, Inc. | 2003 | — |
| −2 | K053451 | Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model… | Moeller Medical GmbH & Co. KG | 2006 | — |
| −1 | K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | 2007 | — |
| 0 (this device) | K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015 | — |
| +1 | K160950 | Miniscav | Sedation Systems, LLC | 2017 | 1 |
| +1 | K170329 | Basic, Dominant Flex | Modela AG | 2017 | 1 |
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 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (5)
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 |
|---|---|---|---|
| * | K130123 | Basic and Dominant Flex Suction PumpsSummary page 6…ge 2 of 5 Medela AG Basic and Dominant Flex Suction Pumps PREDICATE DEVICE(S): Main Predicate: K130123 Basic and Dominant Flex Suction Pumps K063336 Medela Dominant 50 Lipo, model 600-570628 K051749 Cobra Surgical System Octopus… | 2013 |
| * | K063336 | Medela Dominant 50 Lipo, Model 600-5706Summary page 6…Medela AG Basic and Dominant Flex Suction Pumps PREDICATE DEVICE(S): Main Predicate: K130123 Basic and Dominant Flex Suction Pumps K063336 Medela Dominant 50 Lipo, model 600-570628 K051749 Cobra Surgical System Octopus Evolution AS 2010, Class 1 510(k) exempt Urchi… | 2007 |
| * | K051749 | Cobra Surgical SystemSummary page 6…and Dominant Flex Suction Pumps PREDICATE DEVICE(S): Main Predicate: K130123 Basic and Dominant Flex Suction Pumps K063336 Medela Dominant 50 Lipo, model 600-570628 K051749 Cobra Surgical System Octopus Evolution AS 2010, Class 1 510(k) exempt Urchin Evo Stabilizer, Class 1 510(k) exempt DEVICE DES… | 2005 |
| * | — | Octopus Evolution AS 2010 Named without a submission number | |
| * | — | Urchin Evo Stabilizer Named without a submission number | |
| † | K032802 | HK Liposuction Aspirator, Model AP-Iii & AP230-Iii | 2003 |
What descends from it? (2)
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 26 years and passes through 5 companies; a new generation was cleared every 5.4 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K160950 (Sedation Systems, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K130123.
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. 2015, 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 Basic Suction Pump is 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. The Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary…
Read the full statement (161 words)
The Basic Suction Pump is 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. The Basic Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with epicardial ablation probes.
The Dominant Flex Suction Pump is indicated for vacuum extraction, aesthetic body contouring, 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. The Dominant Flex Pump can also be used to provide the vacuum required for use with cardiac tissue stabilizers used in off-pump coronary artery bypass and for use with 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/K150134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150134: Basic, Dominant Flex, KV-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150134
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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