Belmont Equipment Corp.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Belmont Equipment Corp.” (first 1981, latest 2000), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 60 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EAP | Unit, X-Ray, Intraoral | 5 | 5 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 2 |
| EIA | Unit, Operative Dental | 2 | 2 |
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IWZ | Film, Radiographic | 1 | 1 |
Review panels
Most recent Belmont Equipment Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000799 | BELMONT UNIT, MODEL 2000 SERIES | EIA | 2000-05-17 | 65 |
| K983661 | BELMONT UNIT, MODEL 6000 SERIES AND 7500 SERIES | EIA | 1999-01-12 | 85 |
| K963699 | BELRAY/MODEL 096, DENTAL INTRAORAL X-RAY | EHD | 1996-12-23 | 98 |
| K900681 | PANORAMIC MODEL X-CALIBER X-RAY | EAP | 1990-05-23 | 100 |
| K874238 | MODEL 2001 CP, PHOTON I, DENTAL, INTRAORAL X-RAY | EHD | 1987-12-07 | 53 |
| K870300 | BELMONT, PODIATRY X-RAY - REMEX, MODEL PD75 | KPR | 1987-03-25 | 56 |
| K861328 | NEW BELMONT MODEL, MC-5 DENTAL, INTRAORAL X-RAY | EAP | 1986-04-24 | 15 |
| K852019 | BELMONT AUTOPAN-PAN ORAMIC, 098E CEPHALOMETRIC-RAD | EAP | 1985-06-05 | 28 |
| K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | IWZ | 1985-02-21 | 92 |
| K834279 | ACURAY 071A DENTAL INTRAORAL X-RAY | EAP | 1983-12-29 | 37 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Belmont Equipment Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Belmont Instrument Corp. (22 510(k)s)
- Belmont Medical Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Belmont Equipment Corp.?
FDA lists 12 510(k) clearances under the applicant name “Belmont Equipment Corp.” (first 1981, latest 2000), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Belmont Equipment Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Belmont Equipment Corp. is 60 days.
Which FDA product codes appear under Belmont Equipment Corp.?
The most frequent FDA product codes under this applicant name are EAP (Unit, X-Ray, Intraoral, 5); EHD (Unit, X-Ray, Extraoral With Timer, 2); EIA (Unit, Operative Dental, 2).
Next steps
- See all 12 Belmont Equipment Corp. clearances with predicates and recalls
- Run predicate analysis for product code EAP, Belmont Equipment Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.