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

FHQ — Predicate Candidate Screening

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

56 daysmedian FDA review time

463 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K974327	WINGED NEEDLE HOLDER	Phx Technologies Corp.	1998-01-09	52
K924196	LAPAROSCOPIC NEEDLE HOLDER	Nusurg, Inc.	1993-06-25	309
K930330	ENDOSCOPIC NEEDLEHOLDER, MODIFICATION	Holmed Corp.	1993-06-08	137
K920706	MAGNETIC POINT GUARD FOR SURGICAL NEEDLES	Retrax	1993-05-26	463
K851779	25-100,25-220 VARIOUS NEEDLE HOLDERS	Artiberia	1985-06-20	56
K851780	25-230 TO 25-390 VARIOUS NEEDLE HOLDERS	Artiberia	1985-06-20	56
K771859	NEEDLE HOLDER, MICROVASCULAR	Edward Weck, Inc.	1977-10-04	5

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