Atlas FDA

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

Tel-Time Products · Predicate Candidate Screening

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

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K913686SUNSHADES, ACRYLIC LENSES, SILVER COATED #HX-602Tel-Time Products1992-02-111760
K902301SUNSHADES, ACRYLIC LENSES #SG-01Tel-Time Products1990-10-231540
K902385SUNSHADES, ACRYLIC LENSES, ORDER #SG-01Tel-Time Products1990-07-05360

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