Atlas FDA

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

Sutter Biomedical, Inc. — Predicate Candidate Screening

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

55 daysmedian FDA review time
262 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K875249SUTTER PHALANGEAL CAPSutter Biomedical, Inc.1988-02-03430
K870200SUTTER FINGER JOINT PROSTHESISSutter Biomedical, Inc.1987-10-092620
K861983SUTTER LESSER METATARSAL CAPSutter Biomedical, Inc.1986-09-081090
K850274SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENTSutter Biomedical, Inc.1985-04-25920
K830974SUTTER CPM 5000Sutter Biomedical, Inc.1983-04-12150
K830649SUTTER CPM 2000Sutter Biomedical, Inc.1983-03-17160
K823539SUTTER CPMSutter Biomedical, Inc.1983-01-14450
K820813LESSER METATARSAL PHALANG. JOINT PROSTHSutter Biomedical, Inc.1982-05-21590
K820083SUTTER CPMSutter Biomedical, Inc.1982-01-28160
K812691SILICONE IMPLANTSSutter Biomedical, Inc.1981-11-16550
K802342PROXIMAL INTERPHALANGEAL JOINT IMPLANTSutter Biomedical, Inc.1981-10-143830

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