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

Mediatech, Inc. — Predicate Candidate Screening

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

19 daysmedian FDA review time

24 days90th percentile

24clearances measured

K-number	Device	Applicant	Decided	Review days
K860623	CELLGRO HEPES BUFFER SOLUTION	Mediatech, Inc.	1986-03-03	12
K854567	PENICILLIN/STREPTOMYCIN SOLUTION	Mediatech, Inc.	1985-12-06	22
K852602	MCCOY'S 5A MEDIUM-LIQUID FORM	Mediatech, Inc.	1985-07-12	23
K852485	CELLGRO(ISCOVE'S MEDIUM) MODIFICATION	Mediatech, Inc.	1985-07-12	31
K852603	MCCOY'S 5A MEDIUM - POWDERED FORM	Mediatech, Inc.	1985-07-12	23
K852475	CELLGRO WILLIAMS' MEDIUM E	Mediatech, Inc.	1985-07-12	31
K852288	CELLGRO	Mediatech, Inc.	1985-06-04	6
K850510	EMEM W/NEAA-MINIMUM ESSENTIAL MED. W/NON-ESS. AMIN	Mediatech, Inc.	1985-03-04	24
K850524	HBSS-HANKS' BALANCED SALT SOLUTION	Mediatech, Inc.	1985-02-27	19
K850514	ALPHA MEM-ALPHA MINIMUM ESSENTIAL MED. W/O RIBOSID	Mediatech, Inc.	1985-02-27	19
K850522	MEM VITAMINS-MINIMUM ESSENTIAL MEDIUM VITAMINS	Mediatech, Inc.	1985-02-27	19
K850513	RPMI 1640-ROSWELL PARK MEMORIAL INSTITUTE 1640	Mediatech, Inc.	1985-02-27	19
K850520	NEAA-NON-ESSENTIAL AMINO ACIDS	Mediatech, Inc.	1985-02-27	19
K850516	HAM'S F-12-A SPEDIFIC FORMULATION FORM DR. HAM	Mediatech, Inc.	1985-02-27	19
K850526	EBSS W/O CA & MG-EARLE'S BALANCED SALT SOLUTION	Mediatech, Inc.	1985-02-27	19
K850515	HAM'S F-10-A SPEC. FORMULATION FROM DR. HAM	Mediatech, Inc.	1985-02-27	19
K850519	GLUTAMINE-1-GLUTAMINE	Mediatech, Inc.	1985-02-27	19
K850518	NA PYRUVATE-SODIUM PYRUVATE	Mediatech, Inc.	1985-02-27	19
K850512	DMEM-DULBECCO'S MINIMUM ESSENTIAL MEDIUM	Mediatech, Inc.	1985-02-27	19
K850511	EMEM-EARLE'S MINIMUM ESSENTIAL MED. W/GLUTAMINE-EA	Mediatech, Inc.	1985-02-27	19
K850517	MED. 199 W/EARLE'S SALTS-MEDIUM 199 W/EARLES SALTS	Mediatech, Inc.	1985-02-27	19
K850521	MEM AA-MINIMUM ESSENTIAL MEDIUM AMINO ACIDS	Mediatech, Inc.	1985-02-27	19
K850525	DPBS-DULBECCO'S PHOSPHATE BUFFERED SALINE	Mediatech, Inc.	1985-02-27	19
K850523	EBSS-EARLE'S BALANCE SALT SOLUTION	Mediatech, Inc.	1985-02-27	19

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