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

Belmont Equipment Corp. — Predicate Candidate Screening

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

65 daysmedian FDA review time

98 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K000799	BELMONT UNIT, MODEL 2000 SERIES	Belmont Equipment Corp.	2000-05-17	65
K983661	BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES	Belmont Equipment Corp.	1999-01-12	85
K963699	BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY	Belmont Equipment Corp.	1996-12-23	98
K900681	PANORAMIC MODEL X-CALIBER X-RAY	Belmont Equipment Corp.	1990-05-23	100
K874238	MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY	Belmont Equipment Corp.	1987-12-07	53
K870300	BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75	Belmont Equipment Corp.	1987-03-25	56
K861328	NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY	Belmont Equipment Corp.	1986-04-24	15
K852019	BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD	Belmont Equipment Corp.	1985-06-05	28
K844554	BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG	Belmont Equipment Corp.	1985-02-21	92
K834279	ACURAY 071A DENTAL INTRAORAL X-RAY	Belmont Equipment Corp.	1983-12-29	37
K832065	ACURACY 071, DENTAL, INTRAORAL-X-RAY	Belmont Equipment Corp.	1983-09-12	77
K811142	BELMONT PODIATRY MODEL 065 X-RAY	Belmont Equipment Corp.	1981-06-09	43

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