Chrysalis Intelligence · Product Codes · KDN

KDN · System, Perfusion, Kidney

Gastroenterology, Urology · 18 clearances · 8 unique sponsors

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Device class
Class II
Regulation 876.5880
Total clearances
18
2020-01-16 → 2026-07-23
Last 12 months
3
Unique sponsors
8
Classification details
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5880
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
Bridge TO Life 4 0 2025-06-17
Paragonix Technologies, Inc. 4 1 2026-01-30
Traferox Technologies, Inc. 3 1 2026-06-01
Xvivo Perfusion AB 2 1 2026-07-23
S.A.L.F. Spa 2 0 2023-09-21
Institut Georges Lopez 1 0 2021-10-15
Institut Geroges Lopez 1 0 2025-04-25
Pragonix Technologies 1 0 2020-01-16
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
E1632 HCPCS Wearable artificial kidney, each ✓ CMS-verified description Medium HCPCS code for kidney perfusion system supplies and organ preservation
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-23 K261644 Xvivo Perfusion AB Perfadex Plus
2026-06-01 K260456 Traferox Technologies, Inc. VI°Port™ Liver Preservation System
2026-01-30 K254305 Paragonix Technologies, Inc. BAROguard Donor Lung Preservation System
2025-06-17 K243618 Bridge TO Life EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)
2025-05-01 K243870 Traferox Technologies, Inc. X°Port Lung Preservation System; X°Port Lung Preservation Solution
2025-04-25 K243998 Institut Geroges Lopez DCX Disposable Cassette (DCX)
2025-03-31 K243384 Bridge TO Life Belzer UW® Cold Storage Solution (BTLBUW-001)
2025-03-26 K243840 Bridge TO Life Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
2024-11-26 K240650 Traferox Technologies, Inc. LungProtect
2024-10-23 K234060 Paragonix Technologies KIDNEYvault Portable Renal Perfusion System
2023-09-21 K230193 S.A.L.F. Spa Servator P Plus SALF Solution
2023-08-15 K223874 Paragonix Technologies BAROguard
2022-01-20 K211333 Xvivo Perfusion AB KIDNEY ASSIST-transport
2021-10-15 K211224 Institut Georges Lopez RM4 Control Unit
2021-08-19 K202652 S.A.L.F. Spa Servator P SALF Solution with THAM
2021-07-01 K203262 Bridge TO Life, Ltd. Cannula for Organ Perfusion
2020-07-02 K201048 Paragonix Technologies SherpaPak Pediatric Liver Transport System
2020-01-16 K192869 Pragonix Technologies SherpaPak Lung Preservation System , SherpaPak Liver Transport System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence