Atlas FDA

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

Tri-Med Specialties, Inc. — Predicate Candidate Screening

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

203 daysmedian FDA review time
472 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K971615PATTISON ESOPHAGEAL DILATORTri-Med Specialties, Inc.1997-07-24830
K970890#ES-32 SUCTION CATHETER 32 FR.Tri-Med Specialties, Inc.1997-05-23730
K970982T-RX RETRIEVAL FORCEPSTri-Med Specialties, Inc.1997-05-09520
K942918TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETERTri-Med Specialties, Inc.1995-02-282520
K950574NEEDLE/CANNULATri-Med Specialties, Inc.1995-02-24280
K934348TRI-MED QUICK-STEP GASTRIC LAVAGE TUBE SIZES 18FR, 22FR, 32FTri-Med Specialties, Inc.1994-12-234720
K945160PARACENTESIS NEEDLES/CANNULASTri-Med Specialties, Inc.1994-11-14240
K924549TRI-MED QUICK-STEP(TM) RECTAL TUBETri-Med Specialties, Inc.1994-02-105190
K932015TRI-MED INFLATABLE ESOPHAGEAL DILATORTri-Med Specialties, Inc.1994-02-032860
K932652TRI-MED PARACENTESIS TRAYTri-Med Specialties, Inc.1993-11-241750
K931201TRI-MED ENDOSCOPIC FLUID INTRODUCTION CATHETERTri-Med Specialties, Inc.1993-09-282030
K920619TRI-MED GASTRIC LAVAGE SYSTEMTri-Med Specialties, Inc.1992-09-042060
K920527TRI-MED QUICK-STEP GASTRIC LAVAGE KITTri-Med Specialties, Inc.1992-09-042130
K852535E-Z P.E.G. W/PERCUTANEOUS ENDOSCOPY GASTROSTOMYTri-Med Specialties, Inc.1985-10-171250

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