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

Gastrotech, Inc. — Predicate Candidate Screening

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

14 daysmedian FDA review time
237 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K890658SYRINGE INJECTION GUN DELIVERY KITSGastrotech, Inc.1989-10-032370
K890629ESOPHAGEAL OVERTUBEGastrotech, Inc.1989-05-311100
K883336GASTROSTOMY FEEDING TUBEGastrotech, Inc.1988-08-23140
K883351PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBEGastrotech, Inc.1988-08-23140
K862853SYRINGE INJECTION GUNGastrotech, Inc.1986-08-0680

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