510(k) · Cleared
ClearedPAL Single-Use Cannulas
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microaire Surgical Instruments · QPB System, Suction, Lipoplasty For Removal
Cleared on May 14, 2020 as substantially equivalent to K171286 (Microaire Surgical Instruments, LLC, 2017) after a 231-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- May 14, 2020
- Review
- 231 days
- Class
- Class II
- Product code
- QPB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861878 (1986). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK861878 Byron Suction TipsByron Medical · 1986
- 3 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
- 2 generations backK113795 Suction Lipolasty AccessoriesNorman M. Black Iii · 2012
- 1 generation backK171286 PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017
- This deviceK192694 PAL Single-Use CannulasMicroaire Surgical Instruments · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861878 | Byron Suction Tips | Byron Medical | 1986 | — |
| −3 | K981172 | Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles | Byron Medical | 1998 | — |
| −2 | K113795 | Suction Lipolasty Accessories | Norman M. Black Iii | 2012 | — |
| −1 | K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017 | — |
| 0 (this device) | K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K171286 | PAL Multi-Use Cannulas and PAL Manual WandSummary page 6…Page 2 of 6 5. Legally Marketed Predicate Device(s) Predicate Device: K171286, MicroAire® PAL System, Multi-Use Cannula Classification Name: Suction Lipoplasty System Regulation Number:… | 2017 |
| † | K981922 | Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument… | 1998 |
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 34 years and passes through 4 companies; a new generation was cleared every 12.0 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K171286.
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. 2020, 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?
MicroAire® PAL® Single-Use Cannulas are indicated for the removal of tissue or fluid from the body during general surgical procedures, including suction lipoplasty for the purpose of aesthetic body contouring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192694: PAL Single-Use Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192694
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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