510(k) Report

510(k) · Cleared

Cleared

PAL Multi-Use Cannulas and PAL Manual Wand

K171286510(k) TraditionalCleared Oct 13, 2017165-day reviewClass II21 CFR 878.5040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Microaire Surgical Instruments, LLC · QPB System, Suction, Lipoplasty For Removal

Cleared on Oct 13, 2017 as substantially equivalent to K981922 (Microaire Surgical Instruments, Inc., 1998) and 1 other predicate after a 165-day review. Its family tree reaches back 3 generations to 1986. 2 later devices descend from it.

Decided
Oct 13, 2017
Review
165 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K861878 (1986). 4 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2020: 1 descendant cleared2026: 1 descendant clearedK861878 · Byron Suction Tips · Byron Medical · 1986K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 1998K113795 · Suction Lipolasty Accessories · Norman M. Black Iii · 20121990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants K113795 · Suction Lipolasty Accessories · Norman M. Black Iii · 2012K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 1998K861878 · Byron Suction Tips · Byron Medical · 19860
  1. Root · 3 generations backK861878 Byron Suction TipsByron Medical · 1986
  2. 2 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
  3. 1 generation backK113795 Suction Lipolasty AccessoriesNorman M. Black Iii · 2012
  4. This deviceK171286 PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017
  5. Descendant · cites it directly · 0 of its ownK261710 AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula…Apyx Medical Corporation · 2026
  6. Descendant · cites it directly · 0 of its ownK192694 PAL Single-Use CannulasMicroaire Surgical Instruments · 2020

Most influential descendants

Showing 2 of 2 · See all
  • K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation · 2026 · cites it directly0descendants
  • K192694PAL Single-Use CannulasMicroaire Surgical Instruments · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861878Byron Suction TipsByron Medical1986—
−2K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical1998—
−1K113795Suction Lipolasty AccessoriesNorman M. Black Iii2012—
0 (this device)K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017—
+1K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation2026—
+1K192694PAL Single-Use CannulasMicroaire Surgical Instruments2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202610
FIG. 1 — Lineage of K171286, 1986–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K212024 PAL Systemscore 13.7 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K981922Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument…
Summary page 5
…vice Class: Class II Classification Panel: GENERAL AND PLASTIC SURGERY DEVICES 5. Legally Marketed Predicate Device(s) Predicate Device: K981922, MicroAire® Device Cannula, Classification Name: Suction Lipoplasty System Regulation Number:…
Microaire Surgical Instruments, Inc.1998—
*K113795Suction Lipolasty Accessories
Summary page 6
…n: Class II K171286 2 of 5 Reference Device #1: K113795, Black& Black Surgical Inc., Aspiration and Infiltration Cannulas Classification Name: Suction Lipoplasty System, Regulatio…
Norman M. Black Iii2012—

Also cleared against K981922: 3 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K261710AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula AdaptorsApyx Medical Corporation20260
K192694PAL Single-Use CannulasMicroaire Surgical Instruments20200

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 31 years and passes through 3 companies; a new generation was cleared every 12.0 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K261710 (Apyx Medical Corporation, 2026) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K981922.

How does its category compare?

All QPB devices

QPB System, Suction, Lipoplasty For Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.

FDA decisions per year · QPB

5so far in 2026, the most since 2007

2007: 22008: 42009: 12010: 22011: 22012: 32014: 12015: 12016: 12017: 32019: 22020: 22022: 22024: 42025: 22026 (partial year): 5
2007high 5 (2026) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QPB

194in 2024

2008: 69 days median2012: 234 days median2017: 112 days median2024: 194 days median2026 (partial year): 238 days median
2007high 238 (2026) · low 69 (2008)2026

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

2022: 52023: 282024: 162025: 16
2007high 28 (2023) · low 0 (2007)2025

MAUDE reports naming product code QPB, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
200846900
20091—00
20102—00
20112—00
2012323400
20130—00
20141—00
20151—00
20161—00
2017311200
20180—00
20192—00
20202—00
20210—00
20222—05
20230—028
20244194016
20252—016
202652380—

What is it indicated for?

The MicroAire PAL Manual Wand and Multi 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K171286: PAL Multi-Use Cannulas and PAL Manual Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171286

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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