510(k) Report

510(k) · Cleared

Cleared

Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri

K981922510(k) TraditionalCleared Dec 10, 1998192-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, Inc. · QPB System, Suction, Lipoplasty For Removal

Cleared on Dec 10, 1998 after a 192-day review. The FDA summary names no predicate by number. 22 later devices descend from it.

Decided
Dec 10, 1998
Review
192 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
0

22 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2017: 4 descendants cleared2000: 1 descendant cleared2006: 1 descendant cleared2001: 2 descendants cleared2024: 2 descendants cleared2007: 1 descendant cleared2008: 2 descendants cleared2022: 2 descendants cleared2026: 4 descendants cleared2020: 1 descendant cleared2003: 1 descendant cleared2015: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981922 Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty…Microaire Surgical Instruments, Inc. · 1998
  2. Descendant · cites it directly · 13 of its ownK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
  3. Descendant · 2 generations on · 4 of its ownK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
  4. Descendant · 2 generations on · 3 of its ownK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
  5. Descendant · cites it directly · 2 of its ownK171286 PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017
  6. Descendant · 3 generations on · 2 of its ownK150134 Basic, Dominant Flex, KV-6Medela AG · 2015

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2000: 12001: 22003: 12006: 12007: 12008: 22015: 12017: 42020: 12022: 22024: 22026: 4
2000high 4 (2017) · low 0 (2002)2026

Most influential descendants

Showing 5 of 22 · See all
  • K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Moeller Medical GmbH & Co. KG · 2006 · cites it directly13descendants
  • K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007 · 2 generations on4descendants
  • K212024PAL SystemMicroaire Surgical Instruments, LLC · 2022 · 2 generations on3descendants
  • K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC · 2017 · cites it directly2descendants
  • K150134Basic, Dominant Flex, KV-6Medela AG · 2015 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981922Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic…Microaire Surgical Instruments, Inc.1998—
+1K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model…Moeller Medical GmbH & Co. KG2006—
+2K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG2007—
+2K212024PAL SystemMicroaire Surgical Instruments, LLC2022—
+1K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017—
+3K150134Basic, Dominant Flex, KV-6Medela AG2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200120
200310
200610
200710
200820
201510
201740
202010
202220
202420
202640
FIG. 1 — Lineage of K981922, 1998–2026Source: 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
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What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model 00 002 252…Moeller Medical GmbH & Co. KG200613
K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC20172
K992855XPS Straightshot or Model 2000 Microdebrider System or XPS PowersculptXomed, Inc.20002
K010311Lipomatic; Lipomatic Liposuction DeviceEuromi S.A20011

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?

  • Of its descendants, K053451 (Moeller Medical GmbH & Co. KG, 2006) has gone furthest, with 13 descendants of its own.

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.

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® PAD™ System is 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. “K981922: Light Duty Pneumatic Instrument Model Number Pad-100, Heavy Duty Pneumatic Instrument Model Pad-200, Light Duty Electri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981922

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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