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

Highland Metals — Predicate Candidate Screening

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

126 daysmedian FDA review time

176 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K935638	NITINOL, NITI	Highland Metals	1994-05-18	176
K933374	NITI COIL SPRINGS	Highland Metals	1993-11-19	133
K933377	STAINLESS STEEL ARCHES REPACKER RELABETER	Highland Metals	1993-11-16	130
K933378	REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER	Highland Metals	1993-11-12	126
K933380	REVERSE SURVE NITI ARCH WIRE	Highland Metals	1993-11-12	126
K933379	STAINLESS STEEL ARCHES	Highland Metals	1993-11-12	126
K933376	NITI ARCH WIRE ON A SPOOL	Highland Metals	1993-11-12	126

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