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

North Coast Medi-Tek — Predicate Candidate Screening

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

62 daysmedian FDA review time

97 days90th percentile

6clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K870419	IVR-SP CUSTOM ANGIOGRAPHY TRAY	North Coast Medi-Tek	1987-05-11	97	0
K870420	PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY	North Coast Medi-Tek	1987-04-14	70	0
K870416	LP EXTENSION SETS	North Coast Medi-Tek	1987-04-06	62	0
K870418	MYA-1 AND MYT-1 MYELOGRAM TRAY	North Coast Medi-Tek	1987-03-17	42	0
K870417	RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY	North Coast Medi-Tek	1987-03-05	30	0
K854095	BIOPSY TRAY I & II	North Coast Medi-Tek	1985-11-25	49	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