Belmont Instrument Corp.: FDA filings under this applicant name
FDA lists 22 510(k) clearances under the applicant name “Belmont Instrument Corp.” (first 1981, latest 2015), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 30 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 | 1 | 162 |
| 2014 | 1 | 28 |
| 2015 | 1 | 26 |
| 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 |
|---|---|---|---|
| LGZ | Warmer, Thermal, Infusion Fluid | 6 | 6 |
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 5 | 5 |
| DSP | System, Balloon, Intra-Aortic And Control | 5 | 5 |
| FRN | Pump, Infusion | 5 | 5 |
| DPS | Electrocardiograph | 1 | 1 |
Review panels
- General Hospital (11)
- Cardiovascular (6)
- Hematology (5)
Most recent Belmont Instrument Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152208 | The Belmont Hyperthermia Pump | LGZ | 2015-09-02 | 26 |
| K141654 | THE BELMONT RAPID INFUSER | FRN | 2014-07-18 | 28 |
| K131519 | BELMONT HYPERTHERMIA PUMP | LGZ | 2013-11-06 | 162 |
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | 2011-11-16 | 65 |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000 | FRN | 2009-07-01 | 8 |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | BSB | 2009-03-26 | 28 |
| K090089 | BELMONT HYPERTHERMIA PUMP | LGZ | 2009-02-12 | 29 |
| K070654 | HYPERTHERMIA PUMP | LGZ | 2007-06-08 | 91 |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | BSB | 2006-10-19 | 31 |
| K052547 | BELMONT BUDDY FLUID WARMER | BSB | 2005-10-13 | 27 |
12 earlier clearances. See the full list in Caduvo.
Recalls
8 product recalls in 6 recall events; 6 initiated in the last five years. Most recent: 2025-05-13.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Belmont Instrument Corp. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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 Equipment Corp. (12 510(k)s)
- Belmont Medical Technologies (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Belmont Instrument Corp.?
FDA lists 22 510(k) clearances under the applicant name “Belmont Instrument Corp.” (first 1981, latest 2015), across 5 product codes in 3 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 Instrument Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Belmont Instrument Corp. is 30 days.
Which FDA product codes appear under Belmont Instrument Corp.?
The most frequent FDA product codes under this applicant name are LGZ (Warmer, Thermal, Infusion Fluid, 6); BSB (Warmer, Blood, Non-Electromagnetic Radiation, 5); DSP (System, Balloon, Intra-Aortic And Control, 5).
Next steps
- See all 22 Belmont Instrument Corp. clearances with predicates and recalls
- Run predicate analysis for product code LGZ, Belmont Instrument 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.