Atlas FDA

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

Aircast, Inc. — Predicate Candidate Screening

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

133 daysmedian FDA review time
320 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K024019ARTERIALFLOW SYSTEM, MODEL 32AAircast, Inc.2003-06-031800
K023800VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSAAircast, Inc.2003-02-10880
K992454VENAFLOW SYSTEM, MODEL 30AAircast, Inc.2000-01-131740
K964238AIRCAST VENA FLOW STERILE DISPOSABLE CUFFSAircast, Inc.1997-09-083200
K961676AIRCAST VENAFLOW SYSTEM (MODIFICATION)Aircast, Inc.1997-03-283500
K933977AIRCAST EDEMAFLOW SYSTEMAircast, Inc.1993-12-071160
K932900AIRCAST VENAFLOW SYSTEMAircast, Inc.1993-10-251330
K925677AUTOCHILL ACCESSORY KITAircast, Inc.1993-04-142720
K812094AIRCAST PNEUMATIC KNEE BRACEAircast, Inc.1981-08-13200
K810288AIRCAST TENNIS ARM BANDAircast, Inc.1981-02-12100
K780979AIRSTIRRUP PNEUMATIC ANKLE BRACEAircast, Inc.1978-06-30210

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