Atlas FDA

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

Bio Clinic Co. — Predicate Candidate Screening

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

56 daysmedian FDA review time
171 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K930791AMERICAN POWER CONVERSIONS, BACK-UPS 600Bio Clinic Co.1993-08-061710
K932480PRISMBio Clinic Co.1993-07-21580
K926189ORTHODERM CONSUMMATE AIR THERAPY BED W/SCALEBio Clinic Co.1993-06-241980
K921958ELISA TUBE TSH TESTBio Clinic Co.1992-07-02660
K922140ORTHODERM CONVERTIBLE IIBio Clinic Co.1992-05-27210
K921212MIRCO ELISA HPL TEST KITBio Clinic Co.1992-05-07560
K921211NOW PREGNANCY TEST KITBio Clinic Co.1992-05-07560
K920921ELISA TUBE PROLACTIN TEST KITBio Clinic Co.1992-04-08400
K920920ELISA TUBE LH TEST KITBio Clinic Co.1992-04-08400
K920918TMB CHROMOGEN/SUBSTRATE REAGENT SETBio Clinic Co.1992-04-07390
K920917ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAYBio Clinic Co.1992-03-26270
K905156BIO MEDX AIR FLOTATION SYSTEMBio Clinic Co.1990-11-27120
K900131BIO FLOTE(R)Bio Clinic Co.1990-02-16370
K883256BIO THERAPY (TM) ADVANCED PRESSURE RELIEF SYSTEMBio Clinic Co.1988-10-31900

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