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

Radiotherapeutics Corp. — Predicate Candidate Screening

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

85 daysmedian FDA review time

437 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K011220	LEVEEN REFLECT MONOPOLAR/BIPOLAR NEEDLE ELECTRODE	Radiotherapeutics Corp.	2002-07-01	437	0
K012315	LEVEEN ELECTRODE	Radiotherapeutics Corp.	2001-10-11	80	2
K000241	RADIOTHERAPEUTICS RF 3000 RADIOFREQUENCY GENERATOR	Radiotherapeutics Corp.	2000-04-14	78	0
K982556	LEVEEN NEEDLE ELECTRODE	Radiotherapeutics Corp.	2000-04-06	624	11
K000032	LEVEEN NEEDLE ELECTRODE	Radiotherapeutics Corp.	2000-03-30	85	3
K982854	MR COMPATIBLE LEVEEN NEEDLE ELECTRODE	Radiotherapeutics Corp.	1998-11-10	89	0
K981672	RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR	Radiotherapeutics Corp.	1998-07-17	66	0
K972441	RADIOTHERAPEUTICS RF GENERATOR. MODEL #RF-2000	Radiotherapeutics Corp.	1997-09-04	66	0
K962313	MODIFIED LEVEEN NEEDLE ELECTRODE	Radiotherapeutics Corp.	1996-09-11	86	0
K962386	SENSOR SHEATH TS1	Radiotherapeutics Corp.	1996-08-20	61	0
K955144	RADIOTHERAPEUTICS RF GENERATOR MODEL RF-1000	Radiotherapeutics Corp.	1996-04-07	146	0
K950347	LEVEEN NEEDLE ELECTRODE(TM)	Radiotherapeutics Corp.	1995-02-23	27	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