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

Medtec, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

222 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K132908	TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORA	Medtec, Inc.	2014-03-04	168	0
K111340	HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYS	Medtec, Inc.	2011-06-28	47	0
K093738	MRI PATIENT POSITIONING DEVICES	Medtec, Inc.	2010-05-14	161	0
K974703	CARBON FIBER BREAST BOARD	Medtec, Inc.	1998-03-10	84	0
K974700	MATRIX MT-MX3	Medtec, Inc.	1998-03-04	78	0
K973842	CARBON FIBER CONFORMAL COUCH TOP	Medtec, Inc.	1997-12-05	58	7
K962622	INTRA-ORAL THERMOPLASTIC SHIELD	Medtec, Inc.	1996-10-01	88	0
K955236	GREEN TEC-2100	Medtec, Inc.	1996-05-24	192	0
K954705	ACRYSTEEL BLOCKING TRAY	Medtec, Inc.	1996-01-05	85	0
K954456	THERMOPLASTIC SHIELD	Medtec, Inc.	1995-12-21	87	0
K954225	MED-TEC HAND GRIP	Medtec, Inc.	1995-11-14	64	0
K951753	MEDTEC AUTOBLOT 2000	Medtec, Inc.	1995-10-17	183	0
K952729	PAINTED WEDGE & ROD BREAST BOARD	Medtec, Inc.	1995-09-15	92	0
K950293	TEC-2110 GREEN LASER MODEL MT-HNG	Medtec, Inc.	1995-08-18	205	0
K952189	MED-TEC REDISET	Medtec, Inc.	1995-08-09	92	0
K950075	MED-TEC TRAY ADAPTER	Medtec, Inc.	1995-07-13	185	0
K951947	MED-TEC RADIO THERAPY TREATMENT CHAIR	Medtec, Inc.	1995-07-12	77	0
K951679	MED-TEC TESTICULAR SEPARATOR	Medtec, Inc.	1995-07-12	92	0
K951808	MED-TEC REDI-FOAM	Medtec, Inc.	1995-07-06	78	0
K951717	MED-TEC KNEE CRUTCH	Medtec, Inc.	1995-06-28	76	0
K945515	COATED TUNGSTEN EYESHIELD	Medtec, Inc.	1995-06-19	222	0
K950866	HIP FIXATION SYSTEM	Medtec, Inc.	1995-05-30	92	0
K951601	MED-TEC STRING RETICLE TRAY	Medtec, Inc.	1995-05-11	34	0
K950068	CARBON FIBER COUCH INSERT	Medtec, Inc.	1995-04-06	87	0
K943343	FIELD ABUTMENT WEDGE	Medtec, Inc.	1994-12-23	164	0
K943011	TUNGSTEN EYESHIELD	Medtec, Inc.	1994-12-23	182	0
K943802	HP BACK POINTER SYSTEM	Medtec, Inc.	1994-12-07	125	0
K943199	MOTORIZED DEPTH DOSE APPARATUS	Medtec, Inc.	1994-12-07	155	0
K944315	BLOCKING TRAY	Medtec, Inc.	1994-11-22	85	0
K941600	MT-300 CASSETTE HOLDER	Medtec, Inc.	1994-09-16	168	0
K935411	MED-TEC, INC. BREAST BOARD, MT-250	Medtec, Inc.	1994-07-18	251	0
K933227	UNI-FRAME HEAD IMMOBILIZATION SYSTEM	Medtec, Inc.	1994-07-18	381	2
K935300	VAC-LOK IMMOBILIZATION SYSTEM	Medtec, Inc.	1994-07-18	258	0
K941169	TEC 2101 (MODEL MT-HPLGD)	Medtec, Inc.	1994-07-18	126	0
K935412	MED-TEC, INC. BREAST BOARD, MT-200	Medtec, Inc.	1994-07-18	251	0
K942282	MED-TEC BREAST SUPPORT SYSTEM	Medtec, Inc.	1994-07-18	68	0
K941719	360 DEG. ROTATING 1/2 BEAM BLOCK	Medtec, Inc.	1994-07-18	102	0
K935021	HANDI-FOAM	Medtec, Inc.	1994-04-07	169	0
K935760	TEC 2100 (MODEL MT-LPLGD)	Medtec, Inc.	1994-01-25	60	0
K935209	INSTA-FLO	Medtec, Inc.	1993-12-13	45	0
K934519	RADIATION EXIT VERIFICATION SYSTEM/BACK POINTER SYSTEM	Medtec, Inc.	1993-12-13	87	0

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