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

Mcghan Medical Corp. — Predicate Candidate Screening

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

33 daysmedian FDA review time

63 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K873475	MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS	Mcghan Medical Corp.	1987-09-11	11	0
K873476	MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURS	Mcghan Medical Corp.	1987-09-11	11	0
K870754	MCGHAN TISSUE EXPANDER FILL SYSTEM	Mcghan Medical Corp.	1987-03-31	33	0
K864184	MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGN	Mcghan Medical Corp.	1986-12-24	58	0
K864185	MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGN	Mcghan Medical Corp.	1986-12-24	58	0
K862203	MCGHAN MAGNA-SITE(TM) TISSUE EXPANDER	Mcghan Medical Corp.	1986-07-23	43	4
K854794	MCGHAN INTEGRAL VALVE TISSUE EXPANDER	Mcghan Medical Corp.	1985-12-24	22	0
K853014	MCGHAN TISSUE EXPANDER FILL KIT	Mcghan Medical Corp.	1985-09-18	63	1
K843704	MCGHAN TISSUE EXPANDER	Mcghan Medical Corp.	1984-10-31	40	0
K781087	MEDICAL GRADE SILICONE ELASTOMER TUBING	Mcghan Medical Corp.	1978-11-22	146	0
K781700	IONOTPHORETIC APPLICATOR	Mcghan Medical Corp.	1978-11-03	24	0
K781491	PRO-MOLD, CUSTOM EAR	Mcghan Medical Corp.	1978-09-27	30	0
K781356	IMPLANT, EYE SPHERE	Mcghan Medical Corp.	1978-08-21	14	0
K780956	OTOLOGICAL VENTILATION TUBES	Mcghan Medical Corp.	1978-06-22	13	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