510(k) Report

510(k) · Cleared

Cleared

Ranfac Fat Aspiration Cannula

K162932510(k) TraditionalCleared Jan 19, 201791-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

Ranfac, Corp. · MUU System, Suction, Lipoplasty

Cleared on Jan 19, 2017 as substantially equivalent to K060089 (Cell Bio-Systems, Inc., 2006) after a 91-day review. Its family tree reaches back 4 generations to 1986.

Decided
Jan 19, 2017
Review
91 days
Class
Class II
Product code
MUU
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 deviceK162932 Ranfac Fat Aspiration CannulaRanfac, Corp. · 2017
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)K162932Ranfac Fat Aspiration CannulaRanfac, Corp.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K162932, 1986–2017Source: 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 MUU? 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 MUU device

  1. #1 K210528 IntelliFat Disposable Adipose Tissue…score 5.7 · 10 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 4
…Sec. 878.5040 Suction lipoplasty system, Class II Predicate Device: 510(k) Predicate Description Manufactured By Number K060089 Tulip Disposable Cannulas Tulip Medical…
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 31 years and passes through 4 companies; a new generation was cleared every 10.7 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 MUU devices

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

FDA decisions per year · MUU

1in 2022

2007: 12008: 12009: 32010: 42012: 52013: 12014: 42015: 32016: 12017: 72018: 12019: 42020: 22021: 22022: 1
2007high 7 (2017) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUU

190in 2019

2009: 113 days median2010: 58 days median2012: 171 days median2014: 114 days median2015: 269 days median2017: 91 days median2019: 190 days median
2007high 269 (2015) · low 58 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MUU

2in 2017

2007: 12015: 12016: 12017: 2
2007high 2 (2017) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MUU

10in 2025

2007: 22008: 42009: 22010: 42011: 52012: 42013: 212014: 132015: 442016: 202017: 282018: 302019: 352020: 362021: 282022: 502023: 152024: 52025: 10
2007high 50 (2022) · low 2 (2007)2025

MAUDE reports naming product code MUU, 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
20071—12
20081—04
2009311302
201045804
20110—05
2012517104
20131—021
20144114013
20153269144
20161—120
2017791228
20181—030
20194190035
20202—036
20212—028
20221—050
20230—015
20240—05
20250—010
20260—0—

What is it indicated for?

The Ranfac Fat Aspiration Cannula is intended for use in aesthetic body contouring.

If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K162932: Ranfac Fat Aspiration Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162932

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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