Atlas FDA

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

Electronics For Medicine, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
100 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K830791UNIVERSAL MEDDARS SYSTEMElectronics For Medicine, Inc.1983-06-221000
K830795CABINET FOR MULTIPLE FUNCTION BLOCKSElectronics For Medicine, Inc.1983-05-18650
K792528RESPIRATION/APNEA AMPLIFIER MODEL 3105Electronics For Medicine, Inc.1980-02-21760
K791006SMART BILECTRODESElectronics For Medicine, Inc.1979-06-11110
K790198MONITOR PLUG-IN MODEL M1106 ECGElectronics For Medicine, Inc.1979-03-06400
K790203INTERVAL TIMER MODEL V4295Electronics For Medicine, Inc.1979-03-02310
K790185MODEL V 4207 INTEGRATING PLUG-INElectronics For Medicine, Inc.1979-02-16180
K780107ANALYZER-PLUG-IN, CO2 MODEL M 3104Electronics For Medicine, Inc.1978-01-30110
K770366ISOLATED ELECTROCARDIOGRAPH MODEL 1207Electronics For Medicine, Inc.1977-03-0160

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