Atlas FDA

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

Huestis Machine Corp. — Predicate Candidate Screening

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

96 daysmedian FDA review time
493 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K940145COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICEHuestis Machine Corp.1995-01-243860
K926187POSICAST IMMOBILIZATION SYSTEMHuestis Machine Corp.1994-04-154930
K904005HUESTIS FLEXI-BOARDHuestis Machine Corp.1990-11-29920
K901567THE HUESTIS COMPU-PLOTTERHuestis Machine Corp.1990-05-31580
K880047HUESTIS COMPU-FORMERHuestis Machine Corp.1988-04-11960
K792721HUESTIS FLEXI-HOLDERHuestis Machine Corp.1980-02-19500

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