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

Microbio-Medics, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

281 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K923353	VENTILATION TUBES W/ HYDROGEL COATING	Microbio-Medics, Inc.	1993-05-18	314	0
K922572	321Q MINIMUM ENERGY TINNITUS SUPPRESSOR	Microbio-Medics, Inc.	1992-11-02	154	0
K913276	MICROTEK MEDICAL'S SOUND STIKS	Microbio-Medics, Inc.	1991-10-21	90	0
K904239	SOFT HYDROXYLAPATITE OSSICULAR MALLEABLE PROSTHES	Microbio-Medics, Inc.	1991-06-21	281	0
K910167	MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM	Microbio-Medics, Inc.	1991-04-15	90	0
K900726	MICROTEK MEDICAL'S BLOOD COLLECTION KIT	Microbio-Medics, Inc.	1990-05-04	78	0
K901154	MICROTEK'S SURGICAL LAMP HANDLE & COVER	Microbio-Medics, Inc.	1990-03-20	7	0
K895815	MICROTEK TOTAL OSSICULAR PROTHESIS	Microbio-Medics, Inc.	1989-12-26	88	0
K895814	MICROTEK PISTON & WIRE PROSTHESES	Microbio-Medics, Inc.	1989-12-26	88	0
K895502	MICROTEK REUTER-STYLE BI-VALVE INTRANASAL SPLINT	Microbio-Medics, Inc.	1989-12-08	87	0
K885201	OSSICULAR PROSTHESES 4 PARTIAL, 4 TOTAL, 2 CONVERT	Microbio-Medics, Inc.	1989-04-19	124	0
K882422	DISPOSABLE ARACHNOID KNIFE	Microbio-Medics, Inc.	1988-09-06	85	0
K882724	MICROTEK PROBE DRAPE	Microbio-Medics, Inc.	1988-08-03	33	7

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