Atlas FDA

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

Cambridge Medical Instruments, Inc. · Predicate Candidate Screening

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

87 daysmedian FDA review time
181 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K896771EKG, ECG KENZ, ECG 302Cambridge Medical Instruments, Inc.1990-02-26870
K896772EKG, ECG KENZ, ECG 303Cambridge Medical Instruments, Inc.1990-02-26870
K895961MODEL MC6500 ELECTROCARDIOGRAPHCambridge Medical Instruments, Inc.1990-01-04860
K883454MC6700 MULTI-CHANNEL ELECTROCARDIOGRAPHCambridge Medical Instruments, Inc.1989-01-251630
K871993MC 6000 MULTI-CHANNEL ELECTROCARDIOGRAPHCambridge Medical Instruments, Inc.1987-11-231810
K862748MODEL SC-1000 ELECTROCARDIOGRAPH SPECIFICATIONCambridge Medical Instruments, Inc.1986-08-25350
K854282PREVIEW XTCambridge Medical Instruments, Inc.1986-01-08760
K854283CAMBRIDGE MODEL XT1000Cambridge Medical Instruments, Inc.1985-11-13200

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