Chrysalis Intelligence · Product Codes · FMG

FMG · Stopcock, I.V. Set

General Hospital · 5 clearances · 5 unique sponsors

Device class
Class II
Regulation 880.5440
Total clearances
5
2022-05-16 → 2025-04-29
Last 12 months
0
Unique sponsors
5
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5440
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Yomura Technologies, Inc. 1 0 2022-05-16
Elcam Medical Acal 1 0 2022-09-15
Baxter Healthcare Corporation 1 0 2023-03-10
Medex 1 0 2025-04-29
M/S Romsons International 1 0 2023-07-21
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
A4312 HCPCS Insertion tray without drainage bag with indwelling catheter, foley type, two-way, all silicone ✓ CMS-verified description High Catheter/tubing stopcock or valve, typically I.V. set supply
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-29 K242255 Medex Qitexio® 4-Way Stopcock (QIT014)
2023-07-21 K223499 M/S Romsons International Three Way Stop Cock
2023-03-10 K223175 Baxter Healthcare Corporation lntravascular Administration Sets with Stopcock and Manifold
2022-09-15 K211204 Elcam Medical Acal SafePort(TM) Manifold (or Stopcock)
2022-05-16 K210516 Yomura Technologies, Inc. Clicky Cross