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

Micro-Aire Surgical Instruments, Inc. — Predicate Candidate Screening

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

32 daysmedian FDA review time
85 days90th percentile
40clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K904949A.O. SYNTHES,TAP(REPLACEMENT)VARIOUS MODEL NUMBERSMicro-Aire Surgical Instruments, Inc.1990-11-26240
K902676MICROGUARD, ORTHOPEDIC PIN PROTECTORSMicro-Aire Surgical Instruments, Inc.1990-09-14870
K903713OSTEOTOME MODEL NUMBERS 2500-228 & 2500-229Micro-Aire Surgical Instruments, Inc.1990-09-14310
K903650OSCILLATING SAW BLADES # SO-305,MO-305 AND ZO-305Micro-Aire Surgical Instruments, Inc.1990-09-14320
K903664MICRO-AIRE WIRE PASS AND CRANIOTOME DRILLMicro-Aire Surgical Instruments, Inc.1990-09-13300
K901967DENDIA WERK BURS AND CUTTING DISCSMicro-Aire Surgical Instruments, Inc.1990-07-13730
K901735ARTHROSCOPIC SURGERY BLADES DY-3440, 3443, 3444Micro-Aire Surgical Instruments, Inc.1990-06-20640
K902168ARTHROSCOPIC SURGERY BLADES (SEVERAL MODELS)Micro-Aire Surgical Instruments, Inc.1990-06-20360
K900033MICRO-AIRE POWERED MICRO-SURGERY INSTRUMENTSMicro-Aire Surgical Instruments, Inc.1990-02-13420
K900210BONE HARVESTER SYSTEM & OSTEOTOME SYSTEM 2500Micro-Aire Surgical Instruments, Inc.1990-02-02160
K896280MICRO-AIRE OSCILLATING SAW BLADE 202C-25, 202C-50Micro-Aire Surgical Instruments, Inc.1989-11-22220
K894606MICRO-AIRE HIGH SPEED DRILL (2910-000)Micro-Aire Surgical Instruments, Inc.1989-10-13850
K894438MICRO-AIRE CUTTERS FOR MIDAS-REX INSTRUMENTSMicro-Aire Surgical Instruments, Inc.1989-08-21350
K880324MICRO-AIRE CEMENT REMOVAL TOOLSMicro-Aire Surgical Instruments, Inc.1988-02-17220
K874504MICRO-AIRE PULSE LAVAGEMicro-Aire Surgical Instruments, Inc.1987-12-29570
K874503MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTERMicro-Aire Surgical Instruments, Inc.1987-12-02300
K8724901.1 SCREWDRIVERSMicro-Aire Surgical Instruments, Inc.1987-07-23300
K8725501.1 COUPLERS AND 1.2 ADAPTERSMicro-Aire Surgical Instruments, Inc.1987-07-21220
K8724911.1 TWIST DRILLS AND 1.2 CORTICAL DRILLSMicro-Aire Surgical Instruments, Inc.1987-07-16230
K870157OSCILLATING SAW/ RECIPROCATING SAW/ DRILL-REAMERMicro-Aire Surgical Instruments, Inc.1987-02-24420
K863734STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINSMicro-Aire Surgical Instruments, Inc.1986-10-20271
K862922MICRO-AIRE CAST CUTTER BLADESMicro-Aire Surgical Instruments, Inc.1986-08-14130
K862852MICRO-AIRE REPLACE OTOLOGY BURS/ZIM HALL SUR INSTRMicro-Aire Surgical Instruments, Inc.1986-08-11130
K861405REPLACEMENT HOSESMicro-Aire Surgical Instruments, Inc.1986-04-25100
K854331MICRO-AIRE OTO/NEURO DRILL SYSTEMMicro-Aire Surgical Instruments, Inc.1986-01-21850
K854332MICRO-AIRE STAPES DRILL SYSTEMMicro-Aire Surgical Instruments, Inc.1986-01-21850
K851443MICRO-AIRE OSCILLATING SAW, 1740-000 & WIRE DRIVERMicro-Aire Surgical Instruments, Inc.1985-05-03220
K850597MICRO-AIRE HIGH SPEED ORAL SURGERG DRILLMicro-Aire Surgical Instruments, Inc.1985-03-25380
K850483MICRO-AIRE STERNUM SAW REPLACEMENT BLADESMicro-Aire Surgical Instruments, Inc.1985-03-01220
K850497MICRO-AIRE GENERIC BURS & DRILLSMicro-Aire Surgical Instruments, Inc.1985-03-01210
K841165ELECTRO SURGERY SYSTEMMicro-Aire Surgical Instruments, Inc.1984-06-05780
K831714MICRO-AIRE REPLACEMENT SURG. SAW BLADEMicro-Aire Surgical Instruments, Inc.1983-07-07410
K831675TWIST LOCK DRILL 1120Micro-Aire Surgical Instruments, Inc.1983-06-30380
K831230PULSE LAVAGEMicro-Aire Surgical Instruments, Inc.1983-05-18330
K821695MICRO-AIRE REPLAC. DRILL BURS FOR ZIMMERMicro-Aire Surgical Instruments, Inc.1982-07-20420
K820661MICRO-AIRE DISPOSABLE MINI & MAXI LAVAGMicro-Aire Surgical Instruments, Inc.1982-04-21420
K820601REPLACEMENT SAW BLADES FOR STRYKER AIRMicro-Aire Surgical Instruments, Inc.1982-03-23180
K820281MICRO-AIRE REPLACEMENT DRILL BURSMicro-Aire Surgical Instruments, Inc.1982-02-23210
K811506MICRO-AIRE REPLACEMENT SAW BLADESMicro-Aire Surgical Instruments, Inc.1981-08-13780
K811834MICRO OSCILLATING SAWMicro-Aire Surgical Instruments, Inc.1981-07-20200

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