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

R. J. Doyle, Inc. — Predicate Candidate Screening

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

121 daysmedian FDA review time
121 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K89487916GA X 10 MIDDLE SIZE BULLET POINT NEEDLER. J. Doyle, Inc.1989-11-301210
K89487816GA X 6 BULLET POINT NEEDLE, FLEX STAINLESS STEER. J. Doyle, Inc.1989-11-301210
K89488120GA X 7-1/2 THREADING BULLET POINT NEEDLER. J. Doyle, Inc.1989-11-301210
K894882INFILTRATION PUMP SYRINGER. J. Doyle, Inc.1989-11-301210
K89488016GA X 14 FOURTEEN LONG LONG BULLET POINT NEEDLR. J. Doyle, Inc.1989-11-301210
K89487316 GA X 10 BULLET POINT NEEDLER. J. Doyle, Inc.1989-09-22520
K89487520GA X 7-1/2 THREADING BULLET POINT NEEDLER. J. Doyle, Inc.1989-09-22520
K89487414 INCH BULLET POINT NEEDLER. J. Doyle, Inc.1989-09-22520
K89487216 GA X 6 BULLET POINT NEEDLER. J. Doyle, Inc.1989-09-22520
K872200HAMACHER BULLET POINT OPHTHALMIC NEEDLER. J. Doyle, Inc.1987-06-25170

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