Atlas FDA

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

Glenroe Technologies — Predicate Candidate Screening

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

223 daysmedian FDA review time
496 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K980053GLENROE CHAINGlenroe Technologies1998-02-24490
K945535GLENROE ORTHO-SILGlenroe Technologies1995-01-27740
K924351GLENROE ELASTIBITE STIMULATORGlenroe Technologies1994-01-064960
K932920GLENROE PLASTIC BRACKETGlenroe Technologies1993-08-24700
K924140TUFF TIESGlenroe Technologies1993-04-272520
K924139GLENROE ORTHO SEPSGlenroe Technologies1993-04-082330
K924211EJECTORGlenroe Technologies1993-03-312230
K924993GLENROE BAND SEATING CONTOURING INSTRUMENTGlenroe Technologies1992-11-25550

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