Chrysalis Intelligence · Product Codes · KPE

KPE · Container, I.V.

General Hospital · 11 clearances · 7 unique sponsors

Device class
Class II
Regulation 880.5025
Total clearances
11
2020-07-22 → 2026-04-02
Last 12 months
3
Unique sponsors
7
Medical specialty
General Hospital
Review panel
HO
Regulation number
880.5025
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
Epic Medical Pte. , Ltd. 3 0 2025-08-01
Beijing L&Z Medical Technology Development Co., Ltd. 2 1 2026-04-02
Haemotronic S.P.A. 2 0 2021-08-19
Technoflex Sas. 1 0 2025-04-18
Gilero, LLC 1 0 2021-05-06
Fresenius Kabi AG 1 1 2026-01-09
Icu Medical, Inc. 1 1 2026-03-20
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
A4720 HCPCS Dialysate solution, any concentration of dextrose, fluid volume greater than 249 cc, but less than or equal to 999 cc, for peritoneal dialysis ✓ CMS-verified description High Parenteral nutrition solution; standard 2 in 1 formula
A4721 HCPCS Dialysate solution, any concentration of dextrose, fluid volume greater than 999 cc but less than or equal to 1999 cc, for peritoneal dialysis ✓ CMS-verified description High Parenteral nutrition solution; 3 in 1 formulation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-02 K252079 Beijing L&Z Medical Technology Development Co., Ltd. Disposable Infusion Bag for Parenteral Nutrition
2026-03-20 K251980 Icu Medical, Inc. ClaveQS™ Bag
2026-01-09 K251139 Fresenius Kabi AG KabiHelp® Uno; KabiHelp® Advance plus
2025-08-01 K252094 Epic Medical Pte. , Ltd. eZSURE™ Empty Fluid Container
2025-04-18 K250459 Technoflex Sas. DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution
2024-06-21 K241442 Epic Medical Pte. , Ltd. eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
2023-09-01 K223674 Epic Medical Pte. , Ltd. eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
2023-02-16 K222622 Beijing L&Z Medical Technology Development Co., Ltd. Disposable Infusion Bag for Parenteral Nutrition
2021-08-19 K210749 Haemotronic S.P.A. Empty EVA Bag
2021-05-06 K201936 Gilero, LLC SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL
2020-07-22 K193528 Haemotronic S.P.A. Empty EVA Bag