Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MUU — Predicate Candidate Screening
40 FDA 510(k) clearances under this product code; the 50 most recent screened below.
142 daysmedian FDA review time
272 days90th percentile
40clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210528 | IntelliFat Disposable Adipose Tissue Harvesting and Transfer | Millennium Medical Technologies Inc (Dba Cellmyx) | 2022-03-16 | 386 | 0 |
| K203800 | SyntrFuge System | Syntr Health Technologies, Inc. | 2021-07-02 | 186 | 0 |
| K202443 | Smart Kit Basic, Smart Kit Pro | Bsl Co., Ltd. | 2021-03-11 | 197 | 0 |
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | Lifecell Corporation | 2020-05-28 | 160 | 0 |
| K193363 | Dermapose Refresh | Puregraft, LLC | 2020-04-14 | 132 | 0 |
| K182732 | JTL-250-01 | Jointechlabs, Inc. | 2019-11-18 | 416 | 0 |
| K191564 | Progenikine Concentrating System 25 mL System | Emcyte Corporation | 2019-11-07 | 147 | 0 |
| K190386 | KTA Adipose Treatment Kit | Stemics S.A.S | 2019-10-10 | 233 | 0 |
| K190278 | AuraGen 123 Suction Lipoplasty System (A123) | Auragen Aesthetics, LLC | 2019-05-03 | 84 | 0 |
| K172717 | Automatic Tissue Processing Unit | Bsl Co. | 2018-05-25 | 259 | 0 |
| K172714 | LipiVage | Genesis Biosystems, Inc. | 2017-12-08 | 91 | 0 |
| K163647 | Revolve Envi 600 Advanced Adipose System | Lifecell Corporation | 2017-08-25 | 245 | 0 |
| K171242 | Alma LipoFlow System | Alma Lasers, Inc. | 2017-07-14 | 78 | 0 |
| K171135 | Lipogems System | Lipogems International Spa | 2017-05-18 | 31 | 0 |
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500 | Millennium Medical Technologies, Inc. | 2017-03-31 | 44 | 0 |
| K161372 | The Red Head Collection Device, The Jordy Connection System | Miami Fat Supply | 2017-02-24 | 283 | 0 |
| K162932 | Ranfac Fat Aspiration Cannula | Ranfac, Corp. | 2017-01-19 | 91 | 0 |
| K161636 | Lipogems System | Lipogems International Spa | 2016-11-04 | 143 | 0 |
| K150156 | Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack | Ranfac, Corp. | 2015-10-19 | 269 | 0 |
| K150779 | LipoFilter - Hospital Pack, LipoFilter - Clinic Pack | Microaire Surgical Instruments, LLC | 2015-05-22 | 58 | 0 |
| K142073 | ST'RIM | Thiebaud Sas | 2015-04-29 | 272 | 0 |
| K142682 | The Lipogems System | Lipogems International Spa | 2014-12-22 | 94 | 0 |
| K141713 | SMARTGRAFT 200 SYSTEM | Ingeneron, Inc. | 2014-10-28 | 125 | 0 |
| K141591 | SMARTGRAFT 30 SYSTEM | Ingeneron, Inc. | 2014-09-24 | 103 | 0 |
| K132815 | PUREGRAFT 50 SYSTEM | Cytori Therapeutics, Inc. | 2014-01-24 | 137 | 0 |
| K130152 | HYDRASOLVE LIPOPLASTY SYSTEM | Andrew Technologies, LLC | 2013-04-18 | 86 | 0 |
| K121703 | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE | Medi-Khan USA, Inc. | 2012-12-07 | 182 | 0 |
| K121005 | ADIPREP ADIPOSE TRANSFER SYSTEM | Harvest Technologies, Corp. | 2012-09-21 | 171 | 1 |
| K120328 | ORIGINS LIPOHARVESTING SYSTEM | Sound Surgical Technologies, LLC | 2012-09-17 | 228 | 0 |
| K120902 | GID 700 | The Gid Group, Inc. | 2012-08-15 | 142 | 0 |
| K113255 | PUREGRAFT 850/PURE SYSTEM | Cytori Therapeutics, Inc. | 2012-03-07 | 125 | 0 |
| K100114 | FAT CONCENTRATION SYSTEM | Biomet, Inc. | 2010-09-29 | 257 | 0 |
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | Shippert Medical Technologies Corp. | 2010-08-06 | 9 | 0 |
| K101713 | LIPCOLLECTOR II | Human Med AG | 2010-06-29 | 11 | 0 |
| K092923 | CYTORI PUREGRAFT 250/PURE SYSTEM | Cytori Therapeutics, Inc. | 2010-01-06 | 105 | 0 |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | Shippert Medical Technologies Corp. | 2009-12-04 | 113 | 0 |
| K092284 | LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 | Medical Device Resource Corp. | 2009-09-01 | 34 | 0 |
| K083455 | LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100 | Medi-Khan USA, Inc. | 2009-05-18 | 178 | 0 |
| K081848 | LIPOSE FAT TRANSFER SYSTEM | Lipose Corp. | 2008-12-04 | 157 | 0 |
| K072587 | CYTORI AFT SYSTEM | Cytori Therapeutics, Inc. | 2007-12-10 | 87 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda