Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

ArthroCare Corporation — Predicate Candidate Screening

37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

75 daysmedian FDA review time
176 days90th percentile
37clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K254122FLOW FLEXTEND Wand (72290039)ArthroCare Corporation2026-03-301010
K253680LYNX COBLATION Laryngeal Wand (72290254)ArthroCare Corporation2026-03-251240
K240964FLOW 90? WandArthroCare Corporation2024-05-08290
K232290INTELLIO SHIFT SystemArthroCare Corporation2023-12-111320
K230914ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113); WEREWOArthroCare Corporation2023-06-26870
K220563Ambient HipVac 50 Wand with Integrated Finger Switches, RF20ArthroCare Corporation2022-09-011850
K210423Werewolf+ Coblation System, Werewolf+ Controller, Werewolf FArthroCare Corporation2021-06-241330
K202006ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube ArthroCare Corporation2020-12-181500
K192027WEREWOLF COBLATION System, COBLATION HALO WandArthroCare Corporation2019-12-201440
K183346FLOW 90 WandArthroCare Corporation2019-01-24520
K180848AMBIENT Super MULTIVAC 50 Wand with Integrated Finger SwitchArthroCare Corporation2018-05-01290
K172165Q-Fix Suture AnchorArthroCare Corporation2017-08-17300
K163142SpeedStitch Suture Passer; SpeedStitch Suture Cartridges, WhArthroCare Corporation2017-01-06580
K161481Ambient HipVac 50 Wand with Integrated Finger SwitchesArthroCare Corporation2016-10-211430
K162126Ambient KVac Wand with Integrated Finger Switches (Ambient KArthroCare Corporation2016-09-29590
K162074Werewolf RF20000 Controller, FLOW 50 WandArthroCare Corporation2016-08-22260
K153675Paragon T2 Wand with Integrated CableArthroCare Corporation2016-01-15250
K153313SpeedLock Knotless Fixation SystemArthroCare Corporation2015-12-11240
K143235RF20000a Controller, FLOW 50 WandArthroCare Corporation2015-10-233470
K151897MultiFIX® P Knotless Fixation DeviceArthroCare Corporation2015-08-06270
K151660MultiFIX S Knotless Fixation SystemArthroCare Corporation2015-07-16270
K142999EVac 70 Xtra Plasma Wand with Integrated Cable, PROcise XP PArthroCare Corporation2014-11-19333
K140992ARTHROCARE NASASTENT CMC NASAL DRESSINGArthroCare Corporation2014-06-16600
K140521TOPAZ EZ MICRODEBRIDER COBLATION WAND WITH INTEGRATED FINGERArthroCare Corporation2014-06-10980
K140604MULTIFIX S KNOTLESS FIXATION SYSTEMArthroCare Corporation2014-05-14650
K133606N8TIVE ACL ANATOMIC RECONSTRUCTION SYSTEM, N8TIVE ACL FEMORAArthroCare Corporation2014-04-011270
K133727Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILArthroCare Corporation2014-01-16410
K132513Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE ANDArthroCare Corporation2013-09-19380
K1325905.5MM MULTIFIX S KNOTLESS FIXATION DEVICE, 6.5MM MULTIFIX S ArthroCare Corporation2013-09-17290
K132099ARTHROCARE COBLATOR IQ DLR SPINEWAND, ARTHROCARE COBLATOR IQArthroCare Corporation2013-08-22450
K131205ARTHROCARE HEAD AND NECK COBLATION WANDArthroCare Corporation2013-08-091020
K122652ARTHROCARE TURBINATOR WANDArthroCare Corporation2013-07-023050
K123353CIQ CONTROLLER, CIQ WANDSArthroCare Corporation2013-04-051560
K123240SPEEDLOCK HIP KNOTLESS FIXATION IMPLANTArthroCare Corporation2013-02-141210
K120943SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL ArthroCare Corporation2012-09-211760
K120096MULTIFIX P KNOTLESS FIXATION DEVICEArthroCare Corporation2012-03-27750
K111044SPEEDLOCK KNOTLESS FIXATION DEVICE; 3.0MM DRILL; SHARP TIPPEArthroCare Corporation2011-08-091160

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