Cleared Traditional

AK 98 Dialysis Machine (955607) (K250508) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250508 · Vantive US Healthcare, LLC · Gastroenterology & Urology device
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Aug 2025
Decision
161d
Days
Class 2
Risk

K250508 is an FDA 510(k) clearance for the AK 98 Dialysis Machine (955607). Classified as Dialyzer, High Permeability With Or Without Sealed Dialysate System (product code KDI), Class II - Special Controls.

Submitted by Vantive US Healthcare, LLC (Deerfield Lake, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 161 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5860 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vantive US Healthcare, LLC devices

Submission Details

510(k) Number K250508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2025
Decision Date August 01, 2025
Days to Decision 161 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 130d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5860
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System

All 77
Devices cleared under the same product code (KDI) and FDA review panel - the closest regulatory comparables to K250508.
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
K253412 · Outset Medical, Inc. · Jan 2026
FX CorAL 40
K253518 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2025
Purema H Hemoconcentrator - Pediatric
K243920 · Medica USA, Inc. · Sep 2025
2008T HD SYS. CDX BLUESTAR (191124)
K243237 · Fresenius Medical Care Renal Therapies Group, LLC · Jun 2025
5008X Hemodialysis System
K243505 · Fresenius Medical Care Renal Therapies Group, LLC · May 2025
DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO)
K242155 · NIKKISO CO., LTD. · May 2025