510(k) · Cleared
ClearedSuction Lipolasty Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norman M. Black Iii · QPB System, Suction, Lipoplasty For Removal
Cleared on Aug 7, 2012 as substantially equivalent to K981172 (Byron Medical, 1998) after a 228-day review. Its family tree reaches back 2 generations to 1986. 5 later devices descend from it.
- Decided
- Aug 7, 2012
- Review
- 228 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861878 (1986). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK861878 Byron Suction TipsByron Medical · 1986
- 1 generation backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- This deviceK113795 Suction Lipolasty AccessoriesNorman M. Black Iii · 2012
- Descendant · cites it directly · 2 of its ownK171286 PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK261710 AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula…Apyx Medical Corporation · 2026
- Descendant · cites it directly · 0 of its ownK220318 PAL Infiltration SystemMicroaire Surgical Instruments, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK192694 PAL Single-Use CannulasMicroaire Surgical Instruments · 2020
- Descendant · cites it directly · 0 of its ownK132353 Suction Lipoplasty AccessoriesInex · 2014
Most influential descendants
Showing 5 of 5 · See all- K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017 · cites it directly2descendants
- K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation · 2026 · 2 generations on0descendants
- K220318PAL Infiltration SystemMicroaire Surgical Instruments, LLC · 2022 · cites it directly0descendants
- K192694PAL Single-Use CannulasMicroaire Surgical Instruments · 2020 · 2 generations on0descendants
- K132353Suction Lipoplasty AccessoriesInex · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| −1 | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| 0 (this device) | K113795 | Suction Lipolasty Accessories | Norman M. Black Iii | 2012 | — |
| +1 | K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017 | — |
| +2 | K261710 | AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors | Apyx Medical Corporation | 2026 | — |
| +1 | K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | 2022 | — |
| +2 | K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020 | — |
| +1 | K132353 | Suction Lipoplasty Accessories | Inex | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesSummary page 5…Suction Cannulse and Needles Manufacturer: Byron Medical, Inc. 510(k)Number: K981 172 Substantially Equivalence Date: June 30, 1998 Device Description: Black and Black S… | 1998 |
What descends from it? (5)
3 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 2 companies; a new generation was cleared every 14.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K171286 (Microaire Surgical Instruments, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 7 other devices also cite its predicate K981172.
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. 2012, 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 aspiration and infusion cannulae and needles are indicated for aesthetic body contouring and general tissue aspiration.
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/K113795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113795: Suction Lipolasty Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113795
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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