Cleared Traditional

Hemo-Lyte C Cartridge (K202508) - FDA 510(k) Clearance

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

K202508 · Di-Chem, Inc. · Gastroenterology & Urology device
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Aug 2022
Decision
711d
Days
Class 2
Risk

K202508 is an FDA 510(k) clearance for the Hemo-Lyte C Cartridge. Classified as Dialysate Concentrate For Hemodialysis (liquid Or Powder) (product code KPO), Class II - Special Controls.

Submitted by Di-Chem, Inc. (Champlin, US). The FDA issued a Cleared decision on August 12, 2022 after a review of 711 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Di-Chem, Inc. devices

Submission Details

510(k) Number K202508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2020
Decision Date August 12, 2022
Days to Decision 711 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
581d slower than avg
Panel avg: 130d · This submission: 711d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - KPO Dialysate Concentrate For Hemodialysis (liquid Or Powder)

All 28
Devices cleared under the same product code (KPO) and FDA review panel - the closest regulatory comparables to K202508.
pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504
K233159 · Fresenius Medical Care Renal Therapies Group, LLC · Dec 2023
Citric Complete Liquid Citric Acid Concentrate
K223431 · Nipro Renal Solutions USA, Corp. · Aug 2023
NIKKICART
K221652 · Renal Care Dialysis Solutions, S.A. DE C.V. · Mar 2023
Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate
K212620 · Fresenius Medical Care Renal Therapies Group, LLC · May 2022
HMB32 Dialysis Solution
K212052 · Haemopharm Biofluids S.R.L. · Jul 2021
Nipro Dry Complete Dry Acid Concentrate for Hemodialysis
K193155 · Nipro Renal Solutions USA, Corp. · Nov 2020