510(k) Report

510(k) · Cleared

Cleared

Micro-France Liposuction Cannulas

K992282510(k) TraditionalCleared Sep 23, 199978-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

Xomed, Inc. · QPB System, Suction, Lipoplasty For Removal

Cleared on Sep 23, 1999 as substantially equivalent to K981172 (Byron Medical, 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1986.

Decided
Sep 23, 1999
Review
78 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
2

Its longest line of descent runs back 2 generations to K861878 (1986). 3 ancestors in all, the oldest K832520 (1983). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1983: 1 other ancestorK861878 · Byron Suction Tips · Byron Medical · 1986K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 199819801985199019952000
Other ancestors, by generation 1 generation back: 1 other ancestor K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 1998K861878 · Byron Suction Tips · Byron Medical · 19860
  1. Root · 2 generations backK861878 Byron Suction TipsByron Medical · 1986
  2. 1 generation backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
  3. This deviceK992282 Micro-France Liposuction CannulasXomed, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K861878Byron Suction TipsByron Medical1986—
−1K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical1998—
0 (this device)K992282Micro-France Liposuction CannulasXomed, Inc.1999—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
FIG. 1 — Lineage of K992282, 1986–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles
Summary page 5
…touring and general tissue aspiration. Substantial Equivalence The Micro-France liposuction cannulas are substantially equivalent to devices marketed by Byron Medical (K981172) and Wells Johnson Co. (K832520) in their intended use, materials, and overall design. 10
Byron Medical1998—
*K832520Suction Tips
Summary page 5
…ation. Substantial Equivalence The Micro-France liposuction cannulas are substantially equivalent to devices marketed by Byron Medical (K981172) and Wells Johnson Co. (K832520) in their intended use, materials, and overall design. 10
Wells Johnson Co.1983—

Also cleared against K981172: 7 other devices →

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 13 years and passes through 2 companies; a new generation was cleared every 12.0 years on median.
  • None of the 3 ancestors has a recall.
  • 7 other devices also cite its predicate K981172.

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?

Liposuction cannulas are indicated for aesthetic body contouring and general tissue aspiration.

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. “K992282: Micro-France Liposuction Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992282

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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