Cleared Traditional

K791426 - PERITONEAL PAC

K791426 is an FDA 510(k) clearance for PERITONEAL PAC, manufactured by Intermed, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K791426 · Intermed, Inc. · Gastroenterology & Urology device
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Aug 1979
Decision
33d
Days
Class 2
Risk

K791426 is an FDA 510(k) clearance for the PERITONEAL PAC. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Intermed, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 28, 1979 after a review of 33 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 Intermed, Inc. devices

FDA 510(k) Submission Details - K791426

510(k) Number K791426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1979
Decision Date August 28, 1979
Days to Decision 33 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
98d faster than avg
Panel avg: 131d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KDJ Device Classification - Class 2, Special Controls

Product Code KDJ Set, Administration, For Peritoneal Dialysis, Disposable
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 - KDJ Set, Administration, For Peritoneal Dialysis, Disposable

All 101
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K791426.
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
DISPOSABLE PERITONEAL DIALYSIS EXTENSION
K791722 · American Medical Products, Inc. · Nov 1979
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979
SET, ADMINISTRATION, MANUAL, DIALYSIS
K780957 · American Medical Products, Inc. · Jul 1978
FILTER, PERITONEAL DIALY. ADMIN. SET
K772236 · Millipore Corp. · Jan 1978
PERITONEAL DIALYSIS ADMIN. SET
K780082 · Physio-Control Corp. · Jan 1978