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

Med-Tek Corp. — Predicate Candidate Screening

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

78 daysmedian FDA review time

151 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K903234	F-19 TOTAL HIP PROSTHESIS	Med-Tek Corp.	1990-10-10	79
K901687	F-24 FEMORAL HIP PROSTHESIS	Med-Tek Corp.	1990-09-07	148
K901451	F-20 CEMENTED METAL-BACKED ACETABULAR CUP	Med-Tek Corp.	1990-08-31	151
K900428	ANESTHESIA BREATHING CIRCUITS	Med-Tek Corp.	1990-08-17	199
K901626	H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED	Med-Tek Corp.	1990-08-14	127
K901594	H.N. TOTAL HIP PROSTHESIS	Med-Tek Corp.	1990-08-03	120
K901480	F-20 TOTAL HIP PROSTHESIS	Med-Tek Corp.	1990-06-12	77
K901273	L.M.S. SELF-DETACHABLE BROACH WITH STOP	Med-Tek Corp.	1990-06-05	78
K901272	ORION BLADE PLATE FOR TIBIAL OSTEOTOMY	Med-Tek Corp.	1990-04-23	35
K901240	ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED	Med-Tek Corp.	1990-03-26	11
K894978	BACTERIAL FILTER	Med-Tek Corp.	1989-11-02	91
K894906	ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER	Med-Tek Corp.	1989-09-18	48
K812059	SPHGOMOMANOMETER	Med-Tek Corp.	1981-08-13	23
K800614	MEDTEK #411 PORTABLE B-P INSTR.	Med-Tek Corp.	1980-04-02	15
K800222	MODEL 412 ELECTROFLUIDIC MANOMETER	Med-Tek Corp.	1980-02-29	25
K781906	BLOOD PRESSURE DEVICE, 400 SERIES	Med-Tek Corp.	1978-11-16	3

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