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

Dynarad Corp. — Predicate Candidate Screening

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

84 daysmedian FDA review time

636 days90th percentile

9clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K000052	X-RAY MONOBLOCK, MONOBLOCK XRS-60-330	Dynarad Corp.	2000-02-10	34	0
K981267	FACTS MONOBLOCK	Dynarad Corp.	1998-05-06	29	0
K973833	CONTROL, X-RAY DIAGNOSTIC, GENERATOR, HIGH VOLTAGE, ASSEMBLY	Dynarad Corp.	1997-12-30	84	0
K932356	NOVA XM2	Dynarad Corp.	1995-02-08	636	0
K941363	PHANTOM	Dynarad Corp.	1994-07-20	121	1
K932353	HF-110A	Dynarad Corp.	1994-01-31	263	0
K932355	9150A, 1100F	Dynarad Corp.	1993-08-03	82	0
K932354	9170, 1170	Dynarad Corp.	1993-07-23	71	0
K931725	ALPHA II	Dynarad Corp.	1993-07-14	100	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