Atlas FDA

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

Synemed, Inc. — Predicate Candidate Screening

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

73 daysmedian FDA review time
125 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954037FIELD TRENDSynemed, Inc.1995-11-17810
K852936THE FIELDMASTER MODEL 275Synemed, Inc.1985-10-15970
K833274DERMATOLOGY HANDPIECE-OPHTH LASERSynemed, Inc.1983-12-03730
K831085SYNEVAC VACUUM SOURCE UNITSynemed, Inc.1983-06-08650
K828585OPTHALAS PHOTOCOAGULATORSynemed, Inc.1983-01-03410
K822853MODEL 200 SQUIDSynemed, Inc.1982-10-18210
K813282SYNEVAC VACUUM CURETTAGE SYSTEMSSynemed, Inc.1981-12-14270
K811270SCOPE MASTERSynemed, Inc.1981-09-081250

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