Atlas FDA

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

Dyn-A-Med Products · Predicate Candidate Screening

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

47 daysmedian FDA review time
57 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K844121CLAMP, TUBING, LINEDyn-A-Med Products1984-12-17550
K813176GEL ELECTRODEDyn-A-Med Products1981-12-29470
K811157BLADE, TONGUEDyn-A-Med Products1981-05-27290
K802764PLASTIC ADHESIVE BANDAGEDyn-A-Med Products1980-11-24200
K802139SPATULA, CERVICAL CYTOLOGICAL CYTOLOGYDyn-A-Med Products1980-10-31570

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