Atlas FDA

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

Bio Medicus, Inc. — Predicate Candidate Screening

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

86 daysmedian FDA review time
173 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K920761URINE CULTUR STABILIZATION TRANSPORT TUBEBio Medicus, Inc.1992-06-191210
K903410BIO-MEDICUS CANNULA INTRODUCERBio Medicus, Inc.1990-10-31920
K901253(PBS) PORTABLE BYPASS SYSTEM, MODEL 1000Bio Medicus, Inc.1990-09-051730
K901584BIO-MEDICUS BIO CONSOLE MODELS 540 A B CBio Medicus, Inc.1990-06-28850
K894980BIO-CAL 370 HEATER/COOLERBio Medicus, Inc.1989-11-02860
K884129BIO-MEDICUS PERCUTANEOUS CANNULA & INTRODUCER SETBio Medicus, Inc.1988-12-21821
K883956BIO-MEDICUS TUBING CONNECTORSBio Medicus, Inc.1988-10-28390
K872033BIO-MEDICUS CANNULA-TUBINGBio Medicus, Inc.1987-12-071940
K861096CARDIOPULMONARY CANNULA TUBINGBio Medicus, Inc.1986-05-21580
K854133BIO MEDICUS BIO CONSOLE 540Bio Medicus, Inc.1986-01-08900
K853126BIO PACK MODEL 200Bio Medicus, Inc.1985-10-11780
K852698BIO MEDICUS BIO PUMP MODEL BP-80Bio Medicus, Inc.1985-09-30960
K852807BIO MEDICUS BIO PUMP MODEL BP-50Bio Medicus, Inc.1985-09-30900
K851855BIO MEDICUS BIO PUMP MODEL BP-90Bio Medicus, Inc.1985-06-19540
K830858BIO-PROBE SYSTEM-BLOOD FLOW PROBEBio Medicus, Inc.1983-06-08830

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