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

Intl. Medical, Inc. · Predicate Candidate Screening

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

108 daysmedian FDA review time
220 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K970507PEAK FLOW METERIntl. Medical, Inc.1997-06-131230
K943078HOT BIOPSY FORCEPSIntl. Medical, Inc.1994-11-141390
K940370AMERICAN CATHETER E.R.C.P. CANNULAIntl. Medical, Inc.1994-08-172030
K940335AMERICAN CATHETER POLY-SNAREIntl. Medical, Inc.1994-07-211770
K942068AMERICAN CATHETER SPHINCTEROTOMEIntl. Medical, Inc.1994-06-24560
K930406DURHAM; MIN BORE LUER LOCK EXTENSION SETIntl. Medical, Inc.1993-09-032200
K930410DURHAM; LUER LOCK EXTENSION SETIntl. Medical, Inc.1993-09-032200
K923200AMCATH DISPOSABLE CYTOLOGY BRUSHIntl. Medical, Inc.1992-12-071600
K915142AMCATH DISPOSABLE BIOPSY FORCEPSIntl. Medical, Inc.1992-01-10570
K912927AMCATH DISPOSABLE TROCAR AND TROCAR SLEEVEIntl. Medical, Inc.1991-09-19780
K912605AMCATH DISPOSABLE MICRO SCISSORSIntl. Medical, Inc.1991-07-11290
K902555AMCATH COAGULATION PROBEIntl. Medical, Inc.1990-06-20120
K900988AMCATH SUCTION-IRRIGATION TUBEIntl. Medical, Inc.1990-05-07660
K844744CARDIO IV/GXT STRESS TESTING SYSTEMIntl. Medical, Inc.1985-01-23490
K842339COMPUSTRESS STRESS TESTING SYSIntl. Medical, Inc.1984-12-191890
K833728CARDIAC WALL MOTION DEVICEIntl. Medical, Inc.1984-02-101080
K790476QUICKSCAN HOLTER IIIntl. Medical, Inc.1979-06-01880

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