Chrysalis Intelligence · Sponsors · Remington Medical, Inc.

Remington Medical, Inc.

Alpharetta, GA, US · 4 510(k) clearances · 2 recalls

Total clearances
4
2021-10-07 → 2025-11-20
Last 12 months
1
Product codes
1
Most recent
2025-11-20
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
DPW Flowmeter, Blood, Cardiovascular Class II Cardiovascular 4 2025-11-20
Safety

Recalls (2)

Class I (serious)
0
Risk of injury / death
Total recalls
2
Currently ongoing
1
Most recent
2023-11-03
DateSeverityStatusRecall # ProductCodeReason
2023-11-03 Class II Ongoing Z-0487-2024 Remington MEDICAL Drainage Bag, REF 600-D; There is an error with the "Use by Date" and "Date of Manufacturer" on the box label.
2022-12-02 Class II Terminated Z-0771-2023 Remington MEDICAL, Automatic Cutting Needle, 18ga (1.3mm) x 20cm, REF NAC-1820M (1) The stylet is longer than specified on the label
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-11-20 K251904 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01) DPW Class II Cardiovascular
2024-08-30 K241583 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01) DPW Class II Cardiovascular
2022-01-27 K211589 VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger DPW Class II Cardiovascular
2021-10-07 K212065 VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger DPW Class II Cardiovascular