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

Surgical Specialties, Inc. · Predicate Candidate Screening

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

38 daysmedian FDA review time
324 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K932038SUTURE NONABSORBABLE- SILK, POLYESTERSurgical Specialties, Inc.1994-01-072550
K930826SUTURE NONABSORBABLE - SILKSurgical Specialties, Inc.1994-01-073240
K930825SUTURE NONABSORBABLE-NYLON,SILK,POLYESTER,STAINLESSurgical Specialties, Inc.1994-01-073241
K932037SUTURE ABSORBABLE- GUTSurgical Specialties, Inc.1994-01-072550
K874219S3 MEDICATED GAUZESurgical Specialties, Inc.1987-11-23380
K861444S1 NASAL PACKINGSurgical Specialties, Inc.1986-05-06190
K861446S1 ORAL PACKINGSurgical Specialties, Inc.1986-05-06190
K861443S1 VAGINAL PACKINGSurgical Specialties, Inc.1986-05-06190
K861445S1 CAVITY PACKINGSurgical Specialties, Inc.1986-05-06190

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