Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
FDA 510(k) clearance K242735 · decided 2024-12-23
Clearance details
- K-number
- K242735
- Device name
- Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)
- Applicant
- Belmont Medical Technologies
- Decision
- Substantially Equivalent
- Date received
- 2024-09-11
- Decision date
- 2024-12-23
- Days to decision
- 103 days
- Clearance type
- Traditional
- Product code
- FRN
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Billerica, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Belmont Medical Technologies
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consist recall (Z-1678-2025) | Belmont Instrument LLC | 2025-04-25 |
| Belmont Medical 3-Spike Disposable Set used with the Belmont Rapid Infuser RI-2. Designed recall (Z-1099-2025) | Belmont Instrument LLC | 2025-02-04 |