Chrysalis Intelligence · Product Codes · KDJ

KDJ · Set, Administration, For Peritoneal Dialysis, Disposable

Gastroenterology, Urology · 3 clearances · 2 unique sponsors

Device class
Class II
Regulation 876.5630
Total clearances
3
2022-03-18 → 2025-04-03
Last 12 months
0
Unique sponsors
2
Medical specialty
Gastroenterology, Urology
Review panel
GU
Regulation number
876.5630
Implant
N
Life-sustain / support
Y
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Baxter Healthcare Corporation 2 0 2024-03-12
Fresenius Medical Care Renal Therapies Group, LLC 1 0 2025-04-03
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
E1605 HCPCS High HCPCS code for peritoneal dialysis administration set supplies
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-04-03 K250404 Fresenius Medical Care Renal Therapies Group, LLC stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inch
2024-03-12 K231849 Baxter Healthcare MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483
2022-03-18 K214016 Baxter Healthcare Corporation 15L Cycler Drainage Bag