Atlas FDA

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

O.R. Specialties, Inc. · Predicate Candidate Screening

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

98 daysmedian FDA review time
265 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K942607LAPAROSCOPIC SCISSORS (DISPOSABLE)O.R. Specialties, Inc.1994-07-06350
K923630PHACO NEEDLES 1000-R & 1000-O NEEDLESO.R. Specialties, Inc.1994-04-066240
K925671DISPOSABLE SCLERAL PLUGSO.R. Specialties, Inc.1993-08-022650
K923887JACK'S VENT TUBESO.R. Specialties, Inc.1993-02-191990
K923774DISPOSABLE ENDOILLUMINATORO.R. Specialties, Inc.1992-10-19830
K922355POLLY'S VITREOUS SCISSORS J-225-SO.R. Specialties, Inc.1992-08-18910
K922180LEWICKY O.R.S. TUBINGO.R. Specialties, Inc.1992-07-02550
K914038POLLY'S CUTTER J-225O.R. Specialties, Inc.1991-12-09900
K911932J105 JAMES SURGICAL SYSTEM I/A PACKO.R. Specialties, Inc.1991-08-261180
K890195JAMES SURGICAL SYSTEM J1000O.R. Specialties, Inc.1989-08-031970
K891161VITRECTOMY PACK #J120O.R. Specialties, Inc.1989-05-26810
K890825JUMPER PACK #203O.R. Specialties, Inc.1989-05-26980
K880062C-MATE #CMU 1001O.R. Specialties, Inc.1988-03-07600
K811951DRESSING CHANGE TRAYS & STERILE SPONGESO.R. Specialties, Inc.1981-10-161010

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