Atlas FDA

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

Sutter Corp. — Predicate Candidate Screening

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

124 daysmedian FDA review time
344 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943354SUTTER HAMMERTOE JOINT PROSTHESISSutter Corp.1995-06-123350
K945221SUTTER MODEL 6000 HAND CPM DEVICESutter Corp.1995-02-271240
K931588SUTTER PROXIMAL INTERPHALANGEAL JOINTSutter Corp.1994-03-103440
K924654FIRST METATARSOPHALANGEAL JOINT MOTION SPLINTSutter Corp.1993-02-221600
K914860SUTTER MODEL 10000 LEG CPM DEVICESutter Corp.1992-01-08710
K902707MODEL 9000 AT ANKLE CPM DEVICESutter Corp.1990-07-25360
K890607SUTTER HOSPITAL CPMSutter Corp.1989-02-27210

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