Atlas FDA

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

Fibre Formations, Inc. — Predicate Candidate Screening

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

28 daysmedian FDA review time
78 days90th percentile
5clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K791709HEEL/ELBOW PROTECTORSFibre Formations, Inc.1979-09-24280
K790922DISPOSABLE ADULT DIAPERFibre Formations, Inc.1979-07-30760
K781930PANT LINER, DISP. INCONTINENTFibre Formations, Inc.1979-02-01780
K781233IV ARMBOARDSFibre Formations, Inc.1978-08-14260
K781246FOAM COMFORT RINGSFibre Formations, Inc.1978-08-10200

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