510(k) Report

510(k) · Cleared

Cleared

HK Liposuction Aspirator, Model AP-Iii & AP230-Iii

K032802510(k) AbbreviatedCleared Nov 19, 200371-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

Hk Surgical, Inc. · QPB System, Suction, Lipoplasty For Removal

Cleared on Nov 19, 2003 as substantially equivalent to K980392 (Byron Medical, 1998) and 3 other predicates after a 71-day review. Its family tree reaches back 3 generations to 1989. 22 later devices descend from it.

Decided
Nov 19, 2003
Review
71 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K895761 (1989). 4 ancestors in all, the oldest K832274 (1983). 22 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1983: 1 other ancestor2007: 1 descendant cleared2010: 1 descendant cleared2006: 1 descendant cleared2008: 3 descendants cleared2022: 2 descendants cleared2026: 3 descendants cleared2015: 2 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2017: 5 descendants cleared2013: 1 descendant cleared2024: 1 descendant clearedK895761 · General Asperator · Kolster Methods · 1989×2: 2 generations cleared close together, K980392 (1998), K981215 (1998) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 9 descendants4 generations forward: 2 descendants K981215 · Psi-Tec Liposuction Aspirator · Byron Medical · 1998K980392 · Psi-Tec Aspirator · Byron Medical · 1998K895761 · General Asperator · Kolster Methods · 19890
  1. Root · 3 generations backK895761 General AsperatorKolster Methods · 1989
  2. 2 generations backK980392 Psi-Tec AspiratorByron Medical · 1998
  3. 1 generation backK981215 Psi-Tec Liposuction AspiratorByron Medical · 1998
  4. This deviceK032802 HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc. · 2003
  5. Descendant · cites it directly · 13 of its ownK053451 Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction…Moeller Medical GmbH & Co. KG · 2006
  6. Descendant · cites it directly · 4 of its ownK081593 Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008
  7. Descendant · cites it directly · 4 of its ownK063336 Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007
  8. Descendant · 2 generations on · 3 of its ownK212024 PAL SystemMicroaire Surgical Instruments, LLC · 2022
  9. Descendant · 2 generations on · 3 of its ownK092284 Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp. · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12008: 32009: 12010: 12012: 12013: 12015: 22017: 52022: 22024: 12026: 3
2006high 5 (2017) · low 0 (2011)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
  • K081593Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp. · 2008 · cites it directly4descendants
  • K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG · 2007 · cites it directly4descendants
  • K212024PAL SystemMicroaire Surgical Instruments, LLC · 2022 · 2 generations on3descendants
  • K092284Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp. · 2009 · 2 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K895761General AsperatorKolster Methods1989—
−2K980392Psi-Tec AspiratorByron Medical1998—
−1K981215Psi-Tec Liposuction AspiratorByron Medical1998—
0 (this device)K032802HK Liposuction Aspirator, Model AP-Iii & AP230-IiiHk Surgical, Inc.2003—
+1K053451Liposat (Infiltration Pump), Model 00 002 274; Vacusat (Suction Unit), Model…Moeller Medical GmbH & Co. KG2006—
+1K081593Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp.2008—
+1K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG2007—
+2K212024PAL SystemMicroaire Surgical Instruments, LLC2022—
+2K092284Lipisystems Aquavage, Models AV2000 and AV1200Medical Device Resource Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200830
200910
201010
201210
201310
201520
201750
202220
202410
202630
FIG. 1 — Lineage of K032802, 1989–2026Source: 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? (4)

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
*K980392Psi-Tec Aspirator
Summary page 5
…stantially equivalent to the aspiration devices listed below in terms of intended use, design, operating principles, materials and performance. Byron Medical K980392 Byron Medical K98 12 1 5 Kolster Methods K89S76 1 Wells Johnson K832274 6. Device Description: The HK Liposu…
Byron Medical1998—
*K981215Psi-Tec Liposuction Aspirator
Summary page 5
…aspiration devices listed below in terms of intended use, design, operating principles, materials and performance. Byron Medical K980392 Byron Medical K98 12 1 5 Kolster Methods K89S76 1 Wells Johnson K832274 6. Device Description: The HK Liposuction Aspiration Pump is a powe…
Byron Medical1998—
*K895761General AsperatorKolster Methods1989—
*K832274Aspirator
Summary page 5
…ign, operating principles, materials and performance. Byron Medical K980392 Byron Medical K98 12 1 5 Kolster Methods K89S76 1 Wells Johnson K832274 6. Device Description: The HK Liposuction Aspiration Pump is a powered suction pump/ aspirator which uses an electrically…
Wells Johnson Co.1983—

Also cleared against K980392: 2 other devices →

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
K081593Power Aspirator, Model LS2 or LS2DPMedical Device Resource Corp.20084
K063336Medela Dominant 50 Lipo, Model 600-5706Medela AG20074
K092066Phaser Lipoplasty System (Dur-01), Phaser Disposable Kit (Dis-01), Phaser Waste…Andrew Technologies, LLC20102

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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K053451 (Moeller Medical GmbH & Co. KG, 2006) has gone furthest, with 13 descendants of its own.
  • 2 other devices also cite its predicate K980392.

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 HK Liposuction Aspiration Pump is for 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. “K032802: HK Liposuction Aspirator, Model AP-Iii & AP230-Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032802

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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