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

Bio-Med Devices, Inc. — Predicate Candidate Screening

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

90 daysmedian FDA review time
203 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K213948OxyMinderBio-Med Devices, Inc.2022-03-17900
K173973TV-100Bio-Med Devices, Inc.2018-07-202030
K942938CROSSVENT-4 VENTILATORBio-Med Devices, Inc.1995-09-194540
K896381MVP-10 MRI INFANT VENTILATORBio-Med Devices, Inc.1990-02-12980
K896380IC-2A MRI ADULT/PEDIATRIC VENTILATORBio-Med Devices, Inc.1990-02-12980
K873614CBG CUFF MANOMETERBio-Med Devices, Inc.1988-01-221360
K871337M-2 OXYGEN/TEMPERATURE MONITORBio-Med Devices, Inc.1987-06-05630
K871336M-1 PRESSURE MONITORBio-Med Devices, Inc.1987-06-05630
K871139M-10 VENTILATION MONITORBio-Med Devices, Inc.1987-04-21290
K830230PROGRAMMABLE VENTILATORBio-Med Devices, Inc.1983-02-09120
K823861ET-3 EMERGENCY TRANSPORT VENTILATORBio-Med Devices, Inc.1983-02-07470
K813253IC-5 VENTILATORBio-Med Devices, Inc.1981-12-09200
K801890IC-2 VENTILATORBio-Med Devices, Inc.1980-11-181020
K800125VENTILATOR TEST LUNGBio-Med Devices, Inc.1980-01-2460

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