Atlas FDA

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

Healthcheck Corp. — Predicate Candidate Screening

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

35 daysmedian FDA review time
309 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K884489C&T PREGNANCY TEST KITHealthcheck Corp.1989-03-081330
K874818TENSTARHealthcheck Corp.1988-09-283090
K881003DIGITAL BLOOD PRESSURE MONITOR MODEL CX-1Healthcheck Corp.1988-05-18700
K863181HEALTHCHECK THERM-STRIPHealthcheck Corp.1986-09-11230
K861946PTK PLUS. HOME PREGNANCY TESTHealthcheck Corp.1986-06-16270
K860287PULSONIC DIGITAL BLOOD PRESSURE MONITOR MODEL BP-3Healthcheck Corp.1986-04-28900
K851379HEALTHCHECK DIGITAL THERMOMETER MODEL 1 TH-2Healthcheck Corp.1985-04-1240
K850070HEALTHCHECK AUTO INFLATE DIGITAL BP MONITOR BP-2Healthcheck Corp.1985-01-22180
K844281PTK HEALTHCHECK PREGNANCY TEST KITHealthcheck Corp.1984-12-10350

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