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

Specialty Surgical Products, Inc. — Predicate Candidate Screening

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

78 daysmedian FDA review time
161 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K140383ALLOX2 TISSUE EXPANDERSSpecialty Surgical Products, Inc.2014-10-282560
K984106MAMMARY SIZER, MAMMARY PROTHESIS SIZERSpecialty Surgical Products, Inc.1999-02-12870
K983015VIRILIS PENILE PROSTHESISSpecialty Surgical Products, Inc.1999-02-051610
K982258MAMMARY SIZERSpecialty Surgical Products, Inc.1998-09-08740
K982065STERILE SILICONE EXTERNAL WOUND COVERSpecialty Surgical Products, Inc.1998-08-12610
K982067MAGNETIC PORT SILICONE TISSUE EXPANDERSpecialty Surgical Products, Inc.1998-07-13310
K974653SILICONE ELASTOMER SHEETINGSpecialty Surgical Products, Inc.1998-03-13880
K974654SILICONE BLOCKSSpecialty Surgical Products, Inc.1998-02-24710
K974209SILICONE TISSUE/INFLATABLE TISSUE EXPANDERSpecialty Surgical Products, Inc.1998-02-06880
K973656DISPOSABLE SILICONE EPISTAXIS CATHETERSpecialty Surgical Products, Inc.1997-11-18540
K973082VENTRAL WALL DEFECT REDUCTION SILOSpecialty Surgical Products, Inc.1997-11-04780
K973114SILICONE BILIARY STENT/BILIARY CATHETERSpecialty Surgical Products, Inc.1997-09-19300

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