510(k) Report

510(k) · Cleared

Cleared

Lipose Disposable Cannula

K093067510(k) TraditionalCleared Dec 29, 200990-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

Lipose Corp. · QPB System, Suction, Lipoplasty For Removal

Cleared on Dec 29, 2009 as substantially equivalent to K060089 (Cell Bio-Systems, Inc., 2006) after a 90-day review. Its family tree reaches back 4 generations to 1986.

Decided
Dec 29, 2009
Review
90 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.

  1. Root · 4 generations backK861878 Byron Suction TipsByron Medical · 1986
  2. 3 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
  3. 2 generations backK990602 Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999
  4. 1 generation backK060089 Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006
  5. This deviceK093067 Lipose Disposable CannulaLipose Corp. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K861878Byron Suction TipsByron Medical1986—
−3K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical1998—
−2K990602Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services1999—
−1K060089Tulip Disposable CannulasCell Bio-Systems, Inc.2006—
0 (this device)K093067Lipose Disposable CannulaLipose Corp.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K093067, 1986–2009Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K060089Tulip Disposable Cannulas
Summary page 5
…MUU, 21 CFR 878.5040 Predicate Device: Tulip Biomed (formerly Cell Rio-Systems, Inc., USA). Tulip Disposable Cannula, 5 10(k) number K060089 Deyice Description: The Lipose Disposable Cannulas are coated stainless stee…
Cell Bio-Systems, Inc.2006—

Also cleared against K060089: 3 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 23 years and passes through 4 companies; a new generation was cleared every 6.8 years on median.
  • None of the 5 ancestors has a recall.
  • 3 other devices also cite its predicate K060089.

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. 2009, 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 Lipose Disposable Cannula is intended for use in 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. “K093067: Lipose Disposable Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093067

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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