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

Cambridge Instruments, Inc. — Predicate Candidate Screening

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

25 daysmedian FDA review time

67 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K811121	CENTRAL STATION MONITORING SYSTEMS	Cambridge Instruments, Inc.	1981-06-30	67
K811062	CAMPBRIDGE COMPUTRACE	Cambridge Instruments, Inc.	1981-05-29	42
K803229	4-CHANNEL ECG TELEMETRY MON. SYST. #3045	Cambridge Instruments, Inc.	1981-01-13	25
K801224	CAMBRIDGE CARDIAC DIAGNOSTIC SYSTEM	Cambridge Instruments, Inc.	1980-06-26	35
K800566	CAMBRIDGE VS-550 ELECTROCARDIOGRAPH	Cambridge Instruments, Inc.	1980-04-08	26
K792661	TREADMILL MODEL 3060	Cambridge Instruments, Inc.	1980-02-19	55
K791201	SCINTISTRESS SYSTEM	Cambridge Instruments, Inc.	1979-09-17	81
K790509	CARDIOCASSETTE II, AMBULATORY ECG SYSTEM	Cambridge Instruments, Inc.	1979-03-23	8
K761318	3038 OPTION B-COMPUT. TRANS. TERMINAL	Cambridge Instruments, Inc.	1977-01-06	10
K761198	MODEL 3044 3-CHANNEL STRESS TEST SYSTEM	Cambridge Instruments, Inc.	1976-12-09	3
K760926	ELECTROCARDIOGRAPH (MODEL VS-4B)	Cambridge Instruments, Inc.	1976-11-09	11
K760773	IMPEDANCE TESTER (MODEL 4370)	Cambridge Instruments, Inc.	1976-10-08	4
K760776	IMPEDANCE TESTER (MODEL 4390)	Cambridge Instruments, Inc.	1976-10-08	4

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