Atlas FDA

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

Healthteam — Predicate Candidate Screening

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

203 daysmedian FDA review time
203 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890586INFRARED DELUXEHealthteam1989-08-221970
K890585INFRARED HEXHealthteam1989-08-221970
K890588GENTLE EXPRESSIONS ELECTRIC BREAST PUMPHealthteam1989-05-16990
K852459HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8175Healthteam1985-12-302030
K852653HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8115Healthteam1985-12-302030
K852457HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8165Healthteam1985-12-302030
K852458HEALTHTEAM DIGITAL BLOOD PRESSURE KIT 8145Healthteam1985-12-302030
K852460GENTLE EXPRESSIONS AUTOMATIC BREAST PUMP & FEED SYHealthteam1985-11-141570

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