Cleared Traditional

K780082 - PERITONEAL DIALYSIS ADMIN. SET

K780082 is an FDA 510(k) clearance for PERITONEAL DIALYSIS ADMIN. SET, manufactured by Physio-Control Corp.. The device is a Class 2 Gastroenterology & Urology device with product code KDJ cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K780082 · Physio-Control Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1978
Decision
12d
Days
Class 2
Risk

K780082 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS ADMIN. SET. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Physio-Control Corp. (Mchenry, US). The FDA issued a Cleared decision on January 24, 1978 after a review of 12 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 Physio-Control Corp. devices

FDA 510(k) Submission Details - K780082

510(k) Number K780082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1978
Decision Date January 24, 1978
Days to Decision 12 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
118d faster than avg
Panel avg: 130d · This submission: 12d
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 94
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K780082.
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
RINSE BLOCK CONNECTOR
K771482 · Quinton, Inc. · Jan 1978
PERITONEAL CYCLER & MANIFOLD SET
K772136 · Physio-Control Corp. · Dec 1977