510(k) · Cleared
ClearedPsi-Tec Aspirator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Byron Medical · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Mar 5, 1998 as substantially equivalent to K895761 (Kolster Methods, 1989) after a 31-day review. Its family tree reaches back 1 generation to 1989. 27 later devices descend from it.
- Decided
- Mar 5, 1998
- Review
- 31 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K895761 (1989). 27 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK895761 General AsperatorKolster Methods · 1989
- This deviceK980392 Psi-Tec AspiratorByron Medical · 1998
- Descendant · cites it directly · 26 of its ownK981215 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
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K981215Psi-Tec Liposuction AspiratorByron Medical · 1998 · cites it directly26descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895761 | General Asperator | Kolster Methods | 1989 | — |
| 0 (this device) | K980392 | Psi-Tec Aspirator | Byron Medical | 1998 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 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 BTA? 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? (4)
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 |
|---|---|---|---|
| * | K895761 | General AsperatorSummary page 2…tially equivalent to the following legally-marketed devices (“Predicate Devices”) in terms of safety, effectiveness, and intended use: General Aspirator Kolster Methods K895761 Substantial Equivalence Date: Unknown Product: Grams Aspirator Manufacturer: Grams Medical 2443 Norse Ave, Costa Mesa, CAS2627… | 1989 |
| * | — | Grams Aspirator Named without a submission number | |
| * | — | Aspirator and Aspirator II Named without a submission number | |
| * | — | General Aspirator Named without a submission number |
What descends from it? (27)
See all 273 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?
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 PSI-TEC Aspirator(s) indications for use are general surgical
fluids, exudate, soft tissue, and general tissue removal from surgical
sites.
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/K980392 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980392: Psi-Tec Aspirator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980392
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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