Atlas FDA

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

Capintec Instruments, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time
95 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943072BETA C COUNTERCapintec Instruments, Inc.1994-09-29930
K935539CAPINTEC CRC 35RCapintec Instruments, Inc.1994-02-18940
K930962CAPTUS 2000 WEL COUNTERCapintec Instruments, Inc.1993-05-18830
K924586CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARECapintec Instruments, Inc.1992-12-03840
K921428CAPTUS 500Capintec Instruments, Inc.1992-05-28650
K910020CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELSCapintec Instruments, Inc.1991-04-08950
K905796DOSE CALIBRATORCapintec Instruments, Inc.1991-03-18810

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