Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QPB · Predicate Candidate Screening
58 FDA 510(k) clearances under this product code; the 50 most recent screened below.
112 daysmedian FDA review time
290 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251944 | Lipocosm Harmonic System | Lipocosm, LLC | 2026-06-08 | 349 | 0 |
| K253396 | AYON Body Contouring Systemâ„¢ (AYON SYSTEM) | Apyx Medical Corporation | 2026-05-08 | 220 | 0 |
| K252495 | LSSA (NP-200) | Newpong Co., Ltd. | 2026-04-03 | 238 | 0 |
| K244050 | AYON Body Contouring System (AYON SYSTEM) | Apyx Medical Corporation | 2025-05-12 | 132 | 0 |
| K244026 | PAL 7020 Console | Microaire Surgical Instruments, LLC | 2025-04-25 | 116 | 0 |
| K242804 | PAL Aspiration System | Microaire Surgical Instruments, LLC | 2024-12-30 | 104 | 0 |
| K241835 | AirSculpt Body Contouring System (AIRS-1-SYS) | Cellmyx | 2024-11-27 | 155 | 0 |
| K240188 | Vitruvian Liposaber | Black & Black Surgical, Inc. | 2024-09-13 | 233 | 0 |
| K212969 | Liposaver | Lhbiomed Co., Ltd. | 2024-08-07 | 1056 | 0 |
| K220318 | PAL Infiltration System | Microaire Surgical Instruments, LLC | 2022-10-14 | 253 | 0 |
| K212024 | PAL System | Microaire Surgical Instruments, LLC | 2022-06-10 | 346 | 0 |
| K192694 | PAL Single-Use Cannulas | Microaire Surgical Instruments | 2020-05-14 | 231 | 0 |
| K200168 | Dermapose Access | Puregraft, LLC | 2020-04-22 | 90 | 0 |
| K190555 | PowerX Lipo System | Solta Medical | 2019-05-01 | 57 | 0 |
| K190551 | VASERlipo System | Solta Medical | 2019-05-01 | 57 | 0 |
| K171286 | PAL Multi-Use Cannulas and PAL Manual Wand | Microaire Surgical Instruments, LLC | 2017-10-13 | 165 | 0 |
| K170629 | VITRUVIAN INFILTRATION PUMP | Black & Black Surgical, Inc. | 2017-06-22 | 112 | 0 |
| K170329 | Basic, Dominant Flex | Modela AG | 2017-03-24 | 50 | 0 |
| K161722 | VITRUVIAN ULTIMATE ASPIRATOR | Black & Black Surgical, Inc. | 2016-07-26 | 34 | 0 |
| K150134 | Basic, Dominant Flex, KV-6 | Medela AG | 2015-04-21 | 90 | 0 |
| K132353 | SUCTION LIPOPLASTY ACCESSORIES | Inex | 2014-07-30 | 366 | 0 |
| K121218 | HYDRASOLVE CONSOLE STERILE TREATMENT KIT REUSABLE CANNULA, 4 | Andrew Technologies, LLC | 2012-12-13 | 234 | 0 |
| K113128 | MICROAIRE SURGICAL INSTRUMENTS LLC | Microaire Surgical Instruments, LLC | 2012-08-17 | 298 | 2 |
| K113795 | SUCTION LIPOLASTY ACCESSORIES | Norman M. Black Iii | 2012-08-07 | 228 | 0 |
| K110306 | SOUND SURGICAL VASER 2.1 LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-06-23 | 141 | 0 |
| K110255 | SOUND SURGICAL TECHNOLOGIES LLC POWERX LIPO SYSTEM | Sound Surgical Technologies, LLC | 2011-04-04 | 66 | 0 |
| K101413 | EUROMI EVA SP6 | Euromi S.A | 2010-12-16 | 210 | 0 |
| K092066 | PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DI | Andrew Technologies, LLC | 2010-04-12 | 278 | 0 |
| K093067 | LIPOSE DISPOSABLE CANNULA | Lipose Corp. | 2009-12-29 | 90 | 0 |
| K082025 | BODY-JET | Human Med AG | 2008-08-13 | 27 | 1 |
| K081593 | POWER ASPIRATOR, MODEL LS2 OR LS2DP | Medical Device Resource Corp. | 2008-07-23 | 47 | 0 |
| K081039 | LIPO CANNULA | Millennium Medical Technologies, Inc. | 2008-07-10 | 90 | 0 |
| K072793 | LIPOSAT BASIC (INFILTRATION PUMP), MODEL 92-007 688 | Moeller Medical GmbH & Co. KG | 2008-03-04 | 155 | 0 |
| K063336 | MEDELA DOMINANT 50 LIPO, MODEL 600-5706 | Medela AG | 2007-02-26 | 112 | 0 |
| K063235 | CYTORI LIPOPLASTY SYSTEM WITH CELASE REAGENT | Cytori Therapeutics, Inc. | 2007-01-24 | 91 | 0 |
| K053451 | LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCT | Moeller Medical GmbH & Co. KG | 2006-08-25 | 256 | 0 |
| K060089 | TULIP DISPOSABLE CANNULAS | Cell Bio-Systems, Inc. | 2006-04-27 | 105 | 0 |
| K052183 | SORING GMBH SONOCA LIPO | Soring GmbH Medizintechnik | 2005-10-07 | 58 | 0 |
| K042261 | MACROPORE PURICEL LIPOPLASTY SYSTEM | Macropore Biosurgery, Inc. | 2004-09-20 | 28 | 0 |
| K041058 | MISONIX INC. LYSONIX 2000/3000 ULTRASONIC SURGICAL ASPIRATOR | Misonix, Inc. | 2004-05-17 | 24 | 1 |
| K032802 | HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III | Hk Surgical, Inc. | 2003-11-19 | 71 | 0 |
| K031881 | AIRBRUSH LIPOSCULPTOR SYSTEM | Biosculpture Technology, Inc. | 2003-07-28 | 40 | 0 |
| K022051 | SOUNDVASER SYSTEM | Sound Surgical Technologies, LLC | 2002-09-11 | 79 | 2 |
| K012236 | STARS2000 POWER CANNULA | Kmi Kolster Methods, Inc. | 2001-11-19 | 125 | 0 |
| K004005 | MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), | Mentor Corp. | 2001-10-12 | 290 | 0 |
| K012042 | KINETIC CANNULA | Reliance Medical Corp. | 2001-09-20 | 83 | 0 |
| K010311 | LIPOMATIC; LIPOMATIC LIPOSUCTION DEVICE | Euromi S.A | 2001-06-29 | 148 | 0 |
| K010666 | XPS 3000 SYSTEM WITH RECIPROCATING ADAPTER AND SUCTION CANNU | Medtronic Xomed, Inc. | 2001-05-07 | 62 | 0 |
| K001803 | ACCELERATOR RECIPROCATING CANNULA | Byron Medical | 2000-08-04 | 51 | 0 |
| K992855 | XPS STRAIGHTSHOT OR MODEL 2000 MICRODEBRIDER SYSTEM OR XPS P | Xomed, Inc. | 2000-01-21 | 150 | 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