Cleared Traditional

K791342 - ADR-10600(ADR 400)

K791342 is an FDA 510(k) clearance for ADR-10600(ADR 400), manufactured by Physio-Control Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FKX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K791342 · Physio-Control Corp. · Gastroenterology & Urology device
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Nov 1979
Decision
122d
Days
Class 2
Risk

K791342 is an FDA 510(k) clearance for the ADR-10600(ADR 400),10601 (ADR 300). Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Physio-Control Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1979 after a review of 122 days - within the typical 510(k) review window.

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: 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K791342

510(k) Number K791342 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1979
Decision Date November 16, 1979
Days to Decision 122 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
8d faster than avg
Panel avg: 130d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FKX Device Classification - Class 2, Special Controls

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 60
Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K791342.
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361 · Travenol Laboratories, S.A. · Aug 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179 · Erika, Inc. · Feb 1982
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM
K811986 · American Medical Products, Inc. · Aug 1981
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150 · C.R. Bard, Inc. · Nov 1977
RINSE BLOCK ASSEM, D-W PERI. DIALYSIS
K771484 · Quinton, Inc. · Oct 1977