510(k) · Cleared
ClearedPsi-Tec Liposuction Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · QPB System, Suction, Lipoplasty For Removal
Cleared on Jul 1, 1998 as substantially equivalent to K980392 (Byron Medical, 1998) after a 90-day review. Its family tree reaches back 2 generations to 1989. 26 later devices descend from it.
- Decided
- Jul 1, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K895761 (1989). 26 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK895761 General AsperatorKolster Methods · 1989
- 1 generation backK980392 Psi-Tec AspiratorByron Medical · 1998
- This deviceK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
- Descendant · cites it directly · 22 of its ownK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
- Descendant · 2 generations on · 13 of its ownK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
- Descendant · cites it directly · 4 of its ownK081593 Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008
- Descendant · 2 generations on · 4 of its ownK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
- Descendant · 3 generations on · 3 of its ownK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
Showing 5 of 26 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 26 · See all- K032802HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003 · cites it directly22descendants
- K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Moeller Medical GmbH & Co. KG · 2006 · 2 generations on13descendants
- K081593Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008 · cites it directly4descendants
- K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007 · 2 generations on4descendants
- K212024PAL SystemMicroaire Surgical Instruments, LLC · 2022 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| −1 | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| 0 (this device) | K981215 | Psi-Tec Liposuction Aspirator | Byron Medical | 1998 | — |
| +1 | 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 | K081593 | Power Aspirator, Model LS2 or LS2DP | Medical Device Resource Corp. | 2008 | — |
| +2 | K063336 | Medela Dominant 50 Lipo, Model 600-5706 | Medela AG | 2007 | — |
| +3 | K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K980392 | Psi-Tec AspiratorSummary page 6…afety, effectiveness, with a change of intended use: Product: Psi-Tec Aspirator(s) Manufacturer: Byron Medical 3280 East Hemisphere Loop Tucson, AZ 85706 510(k) Number: K980392 Substantial Equivalence Date: 05 March 1998 . -end of summary- 26 | 1998 |
What descends from it? (26)
See all 265 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 9 years and passes through 2 companies; a new generation was cleared every 8.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K032802 (Hk Surgical, Inc., 2003) has gone furthest, with 22 descendants of its own.
- 2 other devices also cite its predicate K980392.
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.
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 PSI-TEC Liposuction Aspirator(s) indications for use is 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/K981215 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981215: Psi-Tec Liposuction Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981215
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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