Atlas FDA

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

Sudormed, Inc. — Predicate Candidate Screening

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

810 daysmedian FDA review time
942 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K936135SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MASudormed, Inc.1996-06-108950
K936240SUDORMED SWEAT PATCH SPECIMENT CONTAINER (PHENCYCLIDINE)Sudormed, Inc.1996-03-198100
K926253SUDORMED SWEAT PATCH SPECIMEN CONTAINER: COCAINESudormed, Inc.1995-07-149420
K935588SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF AMSudormed, Inc.1995-07-146040
K935564SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF OPSudormed, Inc.1995-07-146030
K902442SUDORMED SWEAT PATCH SPECIMEN CONTAINERSudormed, Inc.1990-10-041250

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