510(k) Report

510(k) · Cleared

Cleared

Tulip Disposable Cannulas

K060089510(k) TraditionalCleared Apr 27, 2006105-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

Cell Bio-Systems, Inc. · QPB System, Suction, Lipoplasty For Removal

Cleared on Apr 27, 2006 as substantially equivalent to K981172 (Byron Medical, 1998) and 1 other predicate after a 105-day review. Its family tree reaches back 3 generations to 1986. 17 later devices descend from it.

Decided
Apr 27, 2006
Review
105 days
Class
Class II
Product code
QPB
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K861878 (1986). 4 ancestors in all. 17 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2015: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2017: 1 descendant cleared2019: 1 descendant cleared2010: 2 descendants cleared2012: 2 descendants cleared2020: 1 descendant cleared2014: 3 descendants cleared2018: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant clearedK861878 · Byron Suction Tips · Byron Medical · 1986K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 1998K990602 · Richter Lipoplasty Cannulas and Accessories · Tecsa Technical Services · 19991990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 8 descendants K990602 · Richter Lipoplasty Cannulas and Accessories · Tecsa Technical Services · 1999K981172 · Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and Needles · Byron Medical · 1998K861878 · Byron Suction Tips · Byron Medical · 19860
  1. Root · 3 generations backK861878 Byron Suction TipsByron Medical · 1986
  2. 2 generations backK981172 Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae…Byron Medical · 1998
  3. 1 generation backK990602 Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services · 1999
  4. This deviceK060089 Tulip Disposable CannulasCell Bio-Systems, Inc. · 2006
  5. Descendant · cites it directly · 12 of its ownK081848 Lipose Fat Transfer SystemLipose Corp. · 2008
  6. Descendant · 2 generations on · 8 of its ownK100114 Fat Concentration SystemBiomet, Inc. · 2010
  7. Descendant · 2 generations on · 7 of its ownK121005 Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · Recalled
  8. Descendant · 2 generations on · 2 of its ownK092923 Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010
  9. Descendant · cites it directly · 1 of its ownK142073 ST'RIMThiebaud Sas · 2015

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22012: 22013: 12014: 32015: 22017: 12018: 12019: 12020: 12021: 1
2008high 3 (2014) · low 0 (2011)2026

Most influential descendants

Showing 5 of 17 · See all
  • K081848Lipose Fat Transfer SystemLipose Corp. · 2008 · cites it directly12descendants
  • K100114Fat Concentration SystemBiomet, Inc. · 2010 · 2 generations on8descendants
  • K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp. · 2012 · 2 generations on7descendants
  • K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc. · 2010 · 2 generations on2descendants
  • K142073ST'RIMThiebaud Sas · 2015 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K861878Byron Suction TipsByron Medical1986—
−2K981172Lipoplasty/ Liposuction Aspiration and Tumescent Infusion Cannulae and NeedlesByron Medical1998—
−1K990602Richter Lipoplasty Cannulas and AccessoriesTecsa Technical Services1999—
0 (this device)K060089Tulip Disposable CannulasCell Bio-Systems, Inc.2006—
+1K081848Lipose Fat Transfer SystemLipose Corp.2008—
+2K100114Fat Concentration SystemBiomet, Inc.2010—
+2K121005Adiprep Adipose Transfer SystemHarvest Technologies, Corp.20121
+2K092923Cytori Puregraft 250/Pure SystemCytori Therapeutics, Inc.2010—
+1K142073ST'RIMThiebaud Sas2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201220
201310
201430
201520
201710
201810
201910
202010
202110
FIG. 1 — Lineage of K060089, 1986–2021Source: 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? (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
…40 Identification of Predicate Devices * Byron Medical, Inc. Lipoplasty/Liposuction Aspiration and Tumnescent Infiltration Cannulae/Needles, 5 10(k) number K98 1172, * Richter LTDA. Richter Lipoplasty Carnulas and Accessories, Richter LTDA, Sao Pualo, SP-Brazil, CEP 05047-001; 510(…
Byron Medical1998—
*K990602Richter Lipoplasty Cannulas and Accessories
Summary page 5
…edles, 5 10(k) number K98 1172, * Richter LTDA. Richter Lipoplasty Carnulas and Accessories, Richter LTDA, Sao Pualo, SP-Brazil, CEP 05047-001; 510(k) number K990602 Device Description: The Tulip Disposable Cannulas are coated stainless steel cannulas designed for connection to s…
Tecsa Technical Services1999—

Also cleared against K981172: 7 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K081848Lipose Fat Transfer SystemLipose Corp.200812
K142073ST'RIMThiebaud Sas20151
K162932Ranfac Fat Aspiration CannulaRanfac, Corp.20170
K093067Lipose Disposable CannulaLipose Corp.20090

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 20 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K081848 (Lipose Corp., 2008) has gone furthest, with 12 descendants of its own.
  • 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?

The Tulip 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. “K060089: Tulip Disposable Cannulas.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060089

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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