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

Circadian, Inc. — Predicate Candidate Screening

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

105 daysmedian FDA review time
170 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K921878SCANMATE IIICircadian, Inc.1992-09-111440
K894956CIRCAMED HOLTER VERSION 4Circadian, Inc.1990-02-051850
K874641CIRCADIAN STRESS TEST IICircadian, Inc.1988-04-011400
K874155CIRCAMED MONITOR REMOTE START CONDUCTANCE METERCircadian, Inc.1987-11-23410
K871251CIRCAMED FULL DISCLOSURE SYSTEMCircadian, Inc.1987-05-22530
K860973CIRCADIAN STRESS TEST SYSTEMCircadian, Inc.1986-08-251640
K851517CIRCA MED SINGLE-CHANNEL-AMBULATORY CARDIAC MONITOCircadian, Inc.1985-10-021700
K851643REMOTE CONTROL MODULECircadian, Inc.1985-09-091430
K840741PULMONARY FUNCTION TESTING STSCircadian, Inc.1984-03-05330
K833619CONDUCTANCE METERCircadian, Inc.1984-01-271050
K830830CIRCA MED TWO-CHANNELCircadian, Inc.1983-06-18940
K810698PHARMALOGCircadian, Inc.1981-04-10250
K800214CIRCAMED ICircadian, Inc.1980-02-29280

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