Cleared Traditional

K822361 - DIANEAL SOLUTION EXCHANGE DEVICE #5C4193

K822361 is the FDA 510(k) clearance for DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 by Travenol Laboratories, S.A.. It is a Class 2 Gastroenterology & Urology device (product code FKX) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K822361 · Travenol Laboratories, S.A. · Gastroenterology & Urology device
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Aug 1982
Decision
10d
Days
Class 2
Risk

K822361 is an FDA 510(k) clearance for the DIANEAL SOLUTION EXCHANGE DEVICE #5C4193. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1982 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5630 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K822361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1982
Decision Date August 16, 1982
Days to Decision 10 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 130d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKX System, Peritoneal, Automatic Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5630
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 - FKX System, Peritoneal, Automatic Delivery

All 45
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K822361.
EXTENSION SET TYPE DP
K822658 · Abbott Laboratories · Oct 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712 · Abbott Laboratories · Oct 1982
AUTOMATIC SPLICING DEVICE
K822025 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · Erika, Inc. · Feb 1982
ADR-10600(ADR 400),10601 (ADR 300)
K791342 · Physio-Control Corp. · Nov 1979
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · C.R. Bard, Inc. · Nov 1977