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

Nucletron Corp. — Predicate Candidate Screening

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

118 daysmedian FDA review time

274 days90th percentile

27clearances measured

K-number	Device	Applicant	Decided	Review days
K092804	MICROSELECTRON HDR V2, MODEL 105.999	Nucletron Corp.	2009-10-08	27
K091598	LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797,	Nucletron Corp.	2009-06-29	26
K072445	INTEGRATED BRACHYTHERAPY UNIT - DIGITAL	Nucletron Corp.	2007-09-14	15
K041715	INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001	Nucletron Corp.	2005-03-24	274
K041933	MICROSELECTRON PDR	Nucletron Corp.	2004-08-18	30
K041719	ONCENTRA-VISIR	Nucletron Corp.	2004-07-22	28
K031158	SWIFT 2.0, MODEL 132.001	Nucletron Corp.	2003-08-07	118
K031349	OTP 1.2	Nucletron Corp.	2003-08-07	100
K021286	MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989	Nucletron Corp.	2002-05-23	30
K020015	IMPLANT GUIDANCE SYSTEM APPLICATOR SET	Nucletron Corp.	2002-03-13	69
K010032	SEED SELECTRON MODEL V. 1.0	Nucletron Corp.	2001-10-17	287
K012165	OLDELFT THORASCAN MODEL NUMBER 180T	Nucletron Corp.	2001-09-19	70
K010784	PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.	Nucletron Corp.	2001-04-10	26
K002429	SELECT SEED I-125	Nucletron Corp.	2001-02-02	178
K003270	PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189	Nucletron Corp.	2000-12-22	65
K992303	SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.	Nucletron Corp.	2000-03-27	263
K992434	ITP, MODEL 1.0	Nucletron Corp.	2000-01-13	176
K990990	CET PROSTATE APPLICATOR SET, PART NUMBER 089.066	Nucletron Corp.	1999-10-07	197
K983338	FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095	Nucletron Corp.	1999-04-20	209
K983341	STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAG	Nucletron Corp.	1999-04-15	204
K983115	TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRA	Nucletron Corp.	1999-04-02	210
K983343	PLATO BRACHYTHERAPHY, MODEL V. 14.0	Nucletron Corp.	1999-04-02	191
K983337	ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068	Nucletron Corp.	1999-04-02	191
K980629	VSS, VIRTUAL SIMULATION SYSTEM	Nucletron Corp.	1998-05-06	77
K973848	IBU, INTEGRATED BRACHY THERAPY UNIT	Nucletron Corp.	1998-01-22	106
K964206	NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2	Nucletron Corp.	1997-06-20	242
K940001	PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS)	Nucletron Corp.	1995-11-14	680

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