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

Epcom Medical Systems, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time
129 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K910518GLOVE-N-GEL AMNIOTOMY KITEpcom Medical Systems, Inc.1991-05-09920
K905812INTRAUTERINE CATHETER SETEpcom Medical Systems, Inc.1991-01-31340
K881414CERVICATHEpcom Medical Systems, Inc.1988-06-14710
K871079FETALFLEX FETAL ELECTRODEEpcom Medical Systems, Inc.1987-07-131170
K8443381URO-LOG HOME DIAGNOSTIC PACKEpcom Medical Systems, Inc.1985-02-251090
K844503UROSTRESSTIK DIAGNOSTIC CYSTOMETRY PACKEpcom Medical Systems, Inc.1985-01-02430
K841805OBSTETRICAL DOPPLEREpcom Medical Systems, Inc.1984-06-19490
K831114EPCOM EMS-330 FREEDOM I TELEDOP OBSTETEpcom Medical Systems, Inc.1983-08-121290
K831113EPCOM EMS-310 INTRAPARTUM MONITOREpcom Medical Systems, Inc.1983-08-121290
K831115EPCOM EMS-320 REMOTE MONITORSCOPEEpcom Medical Systems, Inc.1983-08-121290
K831112EPCOM VCU-1 VACUUM SYSTEM & CURETTEEpcom Medical Systems, Inc.1983-06-30860
K813275EPCOM EMS SCAN IIEpcom Medical Systems, Inc.1982-03-311280
K813007EPCOM EMS-180 ANTEPARTUM FETAL MONITOREpcom Medical Systems, Inc.1981-12-10440

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