Atlas FDA

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

Mansfield Scientific, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time
357 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K865017ANGIOSCOPEMansfield Scientific, Inc.1987-12-153570
K870186ENDOMYOCARDIAL BIOPSY DEVICEMansfield Scientific, Inc.1987-02-20350
K855103CIRIBART GYUDUBG CATGETERMansfield Scientific, Inc.1986-02-18570
K853850EXPLORERMansfield Scientific, Inc.1985-12-04790
K852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODEMansfield Scientific, Inc.1985-09-16800
K851848PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETERMansfield Scientific, Inc.1985-07-19840
K844752TRANSVENOUS BALLOON TIPPED(FLOW DIRECTED) TEMP. PAMansfield Scientific, Inc.1985-01-02270
K841705WEDGE PRESSURE CATHETER FLOW DIRECTEDMansfield Scientific, Inc.1984-07-13810

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