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

Dymax Corp — Predicate Candidate Screening

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

71 daysmedian FDA review time

190 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K032135	SITE-RITE IV ULTRASOUND SYSTEM	Dymax Corp	2003-07-21	10
K993624	SITE-RITE 3 ULTRASOUND SYSTEM	Dymax Corp	1999-11-10	15
K931403	SITERITE NEEDLE GUIDE (MODIFIED)	Dymax Corp	1993-07-27	130
K903158	SITERITE NEEDLE GUIDE	Dymax Corp	1990-09-27	71
K894415	DYMAX ENDOVAGINAL BIOPSY GUIDE	Dymax Corp	1989-10-25	100
K862127	DYMAX PERSONAL SCANNER	Dymax Corp	1986-12-11	190
K850478	PLUS 1	Dymax Corp	1985-04-15	63

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