510(k) · Cleared
ClearedSuction Lipoplasty Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inex · QPB System, Suction, Lipoplasty For Removal
Cleared on Jul 30, 2014 as substantially equivalent to K113795 (Norman M. Black Iii, 2012) after a 366-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Jul 30, 2014
- Review
- 366 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K861878 (1986). No later device cites it as a predicate yet.
- Root · 3 generations backK861878 Byron Suction TipsByron Medical · 1986
- 2 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- 1 generation backK113795 Suction Lipolasty AccessoriesNorman M. Black Iii · 2012
- This deviceK132353 Suction Lipoplasty AccessoriesInex · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| −2 | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| −1 | K113795 | Suction Lipolasty Accessories | Norman M. Black Iii | 2012 | — |
| 0 (this device) | K132353 | Suction Lipoplasty Accessories | Inex | 2014 | — |
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 |
|---|---|---|---|
| * | K113795 | Suction Lipolasty AccessoriesSummary page 5…Suction Cannulae and Needles Manufacturer: Black & Black Surgical, Inc. 510(k) Number: KI113795 Substantially Equivalence Date: August 7, 2012 Device Description: INEX Cannulae… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K113795.
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. 2014, 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 cannulac and needles are indicated for aesthetic body contouring and general tissue aspiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132353 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132353: Suction Lipoplasty Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132353
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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