Atlas FDA

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

Advanced Care Products — Predicate Candidate Screening

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

124 daysmedian FDA review time
158 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945846ADVANCE(R) PREGNANCY TESTAdvanced Care Products1995-01-27580
K880472ADVANCE* AND DAISY* PREGNANCY TESTAdvanced Care Products1988-05-161020
K871601ADVANCE* PREGNANCY TEST ACP 2 PREGNANCY TESTAdvanced Care Products1987-08-261240
K853142OVUTIME OVULATION PREDICTOR TESTAdvanced Care Products1985-12-171410
K842265ORTHO BRAND HOME PREGNANCY TESTAdvanced Care Products1984-07-17400
K834270ORTHO ENZYME IMMUNOASSAY HOME PREG.TESTAdvanced Care Products1984-05-141580

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