Cleared Traditional

C.A.P.D. AUTOMATIC HEATER PDH 200 (K842305) - FDA 510(k) Clearance

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

K842305 · Medionics International , Ltd. · Gastroenterology & Urology device
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Jun 1984
Decision
13d
Days
Class 2
Risk

K842305 is an FDA 510(k) clearance for the C.A.P.D. AUTOMATIC HEATER PDH 200. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Medionics International , Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 13 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 Medionics International , Ltd. devices

Submission Details

510(k) Number K842305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date June 25, 1984
Days to Decision 13 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 130d · This submission: 13d
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 32
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K842305.
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406 · Travenol Laboratories, S.A. · Feb 1985
SCD STERILE CONNECTION DEVICE
K844144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885 · Travenol Laboratories, S.A. · Oct 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224 · Travenol Laboratories, S.A. · Feb 1984
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595 · Travenol Laboratories, S.A. · Nov 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065 · Travenol Laboratories, S.A. · Nov 1983