Atlas FDA

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

Nitto Denko America, Inc. · Predicate Candidate Screening

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

16 daysmedian FDA review time
112 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K871441ELECTRODE RTE-3, CLIP-ON DIAGNOSTIC ELECTRODENitto Denko America, Inc.1987-08-031120
K853644NITTO SURGICAL PLASTIC TAPE ST-356Nitto Denko America, Inc.1985-09-19160
K853646NITTO SURGICAL NON-WOVEN TAPE ST-320Nitto Denko America, Inc.1985-09-19160
K853645NITTO SURGICAL CLOTH TAPE ST-330Nitto Denko America, Inc.1985-09-19160
K853647NITTO SURGICAL PAPER TAPE ST-310Nitto Denko America, Inc.1985-09-19160

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