Atlas FDA

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

Medicotest, Inc. · Predicate Candidate Screening

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

90 daysmedian FDA review time
274 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K983597NEUROLINE, DISPOSABLE MONOPOLAR NEEDLE ELECTRODESMedicotest, Inc.1999-01-11900
K970639NEUROLINE, DISPOSABLE REFERENCE AND RECORDING ELECTRODES TYPMedicotest, Inc.1997-05-15840
K961643MEDICOTEST ECG ELECTRODESMedicotest, Inc.1996-12-092240
K952176DISPOSABLE NEUROLOGY ELECTRODES NEUROLINE 7 30 01-KMedicotest, Inc.1995-09-251400
K941568K-10-VS, DA-05-VS, RECORDING ELECTRODESMedicotest, Inc.1994-11-042180
K931430CUTANEOUS ELECTRODEMedicotest, Inc.1993-12-212740
K931426NF-11-E DISPOSABLE REFERENCE/RECORDING ELECTRODEMedicotest, Inc.1993-12-212740
K926264MEDICOTEST SKIN FIXMedicotest, Inc.1993-04-201230
K921579BR-50-J DISPOSABLE ECG ELECTRODEMedicotest, Inc.1992-05-26540
K914672QR-50-E DISPOSABLE RADIOTRANSLUCENT ECG ELECTRODEMedicotest, Inc.1991-10-31130
K902407NF-50-E DISPOSABLE ECG ELECTRODEMedicotest, Inc.1990-07-31610
K901280DISPOSIBLE EEG NEEDLE ELECTRODESMedicotest, Inc.1990-05-11530
K821539MEDICOTEST ELECTRODE PASTEMedicotest, Inc.1982-07-02390
K821506MEDICOTEST ECG ELECTRODESMedicotest, Inc.1982-06-17270

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