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

Norwich Eaton Pharmaceuticals, Inc. — Predicate Candidate Screening

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

31 daysmedian FDA review time
73 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K842841VIVONEX TUNG STEN TIP TUBENorwich Eaton Pharmaceuticals, Inc.1984-08-14250
K831969VIVONEX TUNGSTEN TIP TUBE-WOUNDNorwich Eaton Pharmaceuticals, Inc.1983-09-01730
K831968VIVONEX TUNGSTEN TIP TUBE-BRAIDEDNorwich Eaton Pharmaceuticals, Inc.1983-09-01730
K831971VIVONEX TUNGSTEN TIP TUBE-TWISTED WIRENorwich Eaton Pharmaceuticals, Inc.1983-09-01730
K831970VIVONEX TUNGSTEN TIP TUBE-MONOFILA-Norwich Eaton Pharmaceuticals, Inc.1983-07-18280
K822516VIVONEX MASS GASTRASTOMY TUBENorwich Eaton Pharmaceuticals, Inc.1982-09-07180
K821231VIVONEX TUNGSTEN TIP TUBE PLACEMENTNorwich Eaton Pharmaceuticals, Inc.1982-05-10130
K821067VIVONEX ACUTROL ENTERNAL FEEDING SYSNorwich Eaton Pharmaceuticals, Inc.1982-04-29130
K811968VIVONEX TUNGSTEN TIPNorwich Eaton Pharmaceuticals, Inc.1981-08-25460
K802300VIVONEX JEJUNOSTOMY KITNorwich Eaton Pharmaceuticals, Inc.1980-10-23310

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