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

Telemed Systems, Inc. — Predicate Candidate Screening

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

87 daysmedian FDA review time

112 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days
K020379	PPD BALLOON DILATATION CATHETER	Telemed Systems, Inc.	2002-05-06	90
K013737	MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON	Telemed Systems, Inc.	2002-03-01	108
K010412	FLEXIBLE ENDOSCOPIC SCISSORS	Telemed Systems, Inc.	2001-04-02	49
K992402	5.0 FRENCH X 200CM X 35MM TIP TAPER-20MM CUTTING WIRE, 5.0 F	Telemed Systems, Inc.	1999-12-22	156
K992390	HOT BIOPSY FORCEPS FEENESTRATED 230 CM OVAL CUP, HOT BIOPSY	Telemed Systems, Inc.	1999-12-22	156
K974312	REUSABLE BIOPSY FORCEPS OVAL CUP, REUSABLE BIOSY FORCEPS OVA	Telemed Systems, Inc.	1998-01-21	65
K974300	TELEMED SYSTEMS RETRIEVAL BASKET	Telemed Systems, Inc.	1997-12-19	32
K901435	GASTROINTESTINAL CYTOLOGY BRUSH	Telemed Systems, Inc.	1990-07-16	112
K901427	BILIARY STONE RETRIEVAL AND OCCLUSION BALLOON	Telemed Systems, Inc.	1990-06-22	88
K901424	ESOPHAGEAL BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87
K901425	PYLORIC BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87
K901426	COLONIC BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87
K901433	SURE-FLEX ANASTOMOTIC BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87
K901432	BILIARY BALLOON DILATOR	Telemed Systems, Inc.	1990-06-21	87
K901437	TRANSENDOSCOPIC SCLEROTHERAPHY NEEDLE	Telemed Systems, Inc.	1990-06-18	84
K901431	TELEMED ERCP CANNULA	Telemed Systems, Inc.	1990-06-18	84
K901436	BRONCHIAL CYTOLOGY BRUSH	Telemed Systems, Inc.	1990-06-18	84
K901428	DISPOSABLE GASTROINTESTINAL POLYPECTOMY SNARE	Telemed Systems, Inc.	1990-06-18	84
K901439	DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN	Telemed Systems, Inc.	1990-06-11	77
K901434	PAPILLOTOME	Telemed Systems, Inc.	1990-06-08	74
K901429	SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE	Telemed Systems, Inc.	1990-06-05	71
K901438	SURE-STOP TRANSBRONCHIAL ASPIRATION NEEDLE	Telemed Systems, Inc.	1990-05-24	59

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