Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Belmont Instrument Corp. · Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
51 daysmedian FDA review time
339 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131519 | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2013-11-06 | 162 | 0 |
| K112639 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2011-11-16 | 65 | 0 |
| K091855 | THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUS | Belmont Instrument Corp. | 2009-07-01 | 8 | 1 |
| K090508 | THE BELMONT BUDDY LITE FLUID WARMER | Belmont Instrument Corp. | 2009-03-26 | 28 | 0 |
| K090089 | BELMONT HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2009-02-12 | 29 | 0 |
| K070654 | HYPERTHERMIA PUMP | Belmont Instrument Corp. | 2007-06-08 | 91 | 0 |
| K062774 | BELMONT BUDDY PLUS FLUID WARMER | Belmont Instrument Corp. | 2006-10-19 | 31 | 0 |
| K052547 | BELMONT BUDDY FLUID WARMER | Belmont Instrument Corp. | 2005-10-13 | 27 | 0 |
| K032778 | LARGE VOLUME FLUID RESERVOIR | Belmont Instrument Corp. | 2003-09-22 | 14 | 0 |
| K032674 | BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000 | Belmont Instrument Corp. | 2003-09-16 | 18 | 1 |
| K031478 | MICROHEATER | Belmont Instrument Corp. | 2003-07-02 | 51 | 0 |
| K983866 | BELMONT MODEL NGPBP INTRA-AORTIC BALLOON PUMP | Belmont Instrument Corp. | 2000-01-06 | 430 | 0 |
| K992672 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | Belmont Instrument Corp. | 1999-08-24 | 14 | 0 |
| K983975 | BELMONT FLUID MANAGEMENT SYSTEM (FMS2000) | Belmont Instrument Corp. | 1998-11-30 | 21 | 0 |
| K982538 | BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP | Belmont Instrument Corp. | 1998-10-02 | 73 | 0 |
| K972284 | FLUID MANAGEMENT SYSTEM | Belmont Instrument Corp. | 1997-11-13 | 147 | 1 |
| K952576 | TRANSPORT CART | Belmont Instrument Corp. | 1995-12-26 | 204 | 0 |
| K950687 | EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) | Belmont Instrument Corp. | 1995-05-24 | 99 | 0 |
| K915580 | BELMONT MODEL PBP INTRA-AORTIC BALLOON PUMP | Belmont Instrument Corp. | 1992-10-30 | 339 | 0 |
| K810104 | ECG ARRHYTHMIA STIMULATOR | Belmont Instrument Corp. | 1981-01-29 | 13 | 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