Atlas FDA

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

Cooper-Hewitt Electric Co. — Predicate Candidate Screening

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

35 daysmedian FDA review time
364 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K860132AIR CARE AIR SANITIZERCooper-Hewitt Electric Co.1987-01-133640
K862608SPERTILITE PHOTOTHERAPY LAMPCooper-Hewitt Electric Co.1986-08-06290
K813049AQUANOMICS, #HHU100Cooper-Hewitt Electric Co.1981-12-02350
K813045AQUANOMICS, #SP36SFCooper-Hewitt Electric Co.1981-12-02350
K813048AQUANOMICS, #MP2SFCooper-Hewitt Electric Co.1981-12-02350
K813050AQUANOMICS, #MP4SFCooper-Hewitt Electric Co.1981-12-02350
K813047AQUANOMICS, MINI 60LCooper-Hewitt Electric Co.1981-12-02350
K813046AQUANOMICS, #HHU60Cooper-Hewitt Electric Co.1981-12-02350

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