Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Medix Medical Electronics (U.S.A.), Inc. · Predicate Candidate Screening

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

62 daysmedian FDA review time
97 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K861040ENTERNAL INFUSER MULTIPUMP 203Medix Medical Electronics (U.S.A.), Inc.1986-06-23970
K861001PARENTERAL INFUSER MEDIPUMP 204Medix Medical Electronics (U.S.A.), Inc.1986-06-12860
K853393INSULIN PUMP INSUMAT 229Medix Medical Electronics (U.S.A.), Inc.1985-11-18980
K852433INFUSAFE 205 CATOLOG NO. 205.000Medix Medical Electronics (U.S.A.), Inc.1985-06-27170
K813562SYRINGE DRIVER 209Medix Medical Electronics (U.S.A.), Inc.1982-02-01410
K812039SPIROMETER 210/211Medix Medical Electronics (U.S.A.), Inc.1981-09-25660
K812041VENTI-MONITOR MODEL 101Medix Medical Electronics (U.S.A.), Inc.1981-09-25660
K812045INFANT APNEA MONITOR MODEL 100Medix Medical Electronics (U.S.A.), Inc.1981-09-24650
K812040OXYGEN MONITOR 140/141Medix Medical Electronics (U.S.A.), Inc.1981-09-21620
K812046TIDAL VOLUME MONITOR 150Medix Medical Electronics (U.S.A.), Inc.1981-08-07170
K812044RESPIRATION RATE MONITOR 120/121Medix Medical Electronics (U.S.A.), Inc.1981-08-04140
K812042INFUSION PUMP MODEL 200/201Medix Medical Electronics (U.S.A.), Inc.1981-07-31100
K812037TEMPERATURE MONITOR 130/131/133Medix Medical Electronics (U.S.A.), Inc.1981-07-2870
K812038OXYGEN CONTROLLER MODEL 145Medix Medical Electronics (U.S.A.), Inc.1981-07-2100

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