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

Micromed Development Corp. — Predicate Candidate Screening

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

35 daysmedian FDA review time

61 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K945105	POLY/PLATINUM WIRE PISTON	Micromed Development Corp.	1996-05-14	574
K945831	DISPOSABLE JOINT ASPIRATION/INJECTION DIAGNOSTIC KIT	Micromed Development Corp.	1995-01-20	52
K945242	NERVE MONITOR ELECTRODES/STIMULATOR PROBES	Micromed Development Corp.	1994-12-27	61
K945104	MICROMED PARTIAL REGULAR AND PARTIAL OFFSET	Micromed Development Corp.	1994-11-22	35
K945106	MICROMED TOTAL REGULAR AND PARTIAL OFFSET	Micromed Development Corp.	1994-11-22	35
K945438	EDI-BUR MICRODRILL SYSTEMS	Micromed Development Corp.	1994-11-22	33
K945107	POLY-WIRE PISTON	Micromed Development Corp.	1994-11-22	35
K945108	POLY PISTON	Micromed Development Corp.	1994-11-22	35
K943848	COLLAR BUTTON VENTURI VENT TUBE	Micromed Development Corp.	1994-09-16	43
K943847	BOBBIN STYLE VENTURI VENT TUBE	Micromed Development Corp.	1994-09-02	29
K943849	GROMMENT STYLE VENTURI TUBE	Micromed Development Corp.	1994-09-02	29
K943281	POLYETHYLENE VENT TUBES	Micromed Development Corp.	1994-08-24	48
K943190	C-FLEX VENT TUBES	Micromed Development Corp.	1994-08-24	50
K942724	EXTERNAL NASAL SPLINT	Micromed Development Corp.	1994-07-08	29

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