Atlas FDA

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

Technical Products, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time
242 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K013321SILICONE TRACHEAL T-TUBESTechnical Products, Inc.2002-06-042420
K973385OVAL SHAPESTechnical Products, Inc.1997-12-05880
K973166DOW CORNING SILASTIC ELASTOMER Q7-4750Technical Products, Inc.1997-11-21880
K971472SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPATechnical Products, Inc.1997-07-01690
K971613SIL-TEC SMALL/LARGE BORE TUBING/SIL-TEC HIGH DUROMETER TUBINTechnical Products, Inc.1997-05-22200
K954116SILICONE MALECOT CATHETER WITH PEZZER/MUSHROOM TIPTechnical Products, Inc.1995-11-061090

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