Atlas FDA

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

Microaire Surgical Instruments, LLC — Predicate Candidate Screening

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

165 daysmedian FDA review time
346 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC2025-06-202120
K244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLC2025-04-251160
K242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC2024-12-301040
K220318PAL Infiltration SystemMicroaire Surgical Instruments, LLC2022-10-142530
K212024PAL SystemMicroaire Surgical Instruments, LLC2022-06-103460
K181819SMARTRELEASE Endoscopic Soft Tissue Release SystemMicroaire Surgical Instruments, LLC2018-11-061200
K171286PAL Multi-Use Cannulas and PAL Manual WandMicroaire Surgical Instruments, LLC2017-10-131650
K150779LipoFilter - Hospital Pack, LipoFilter - Clinic PackMicroaire Surgical Instruments, LLC2015-05-22580
K113128MICROAIRE SURGICAL INSTRUMENTS LLCMicroaire Surgical Instruments, LLC2012-08-172982

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