Cleared Traditional

K780957 - SET

K780957 is the FDA 510(k) clearance for SET by American Medical Products, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K780957 · American Medical Products, Inc. · Gastroenterology & Urology device
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Jul 1978
Decision
24d
Days
Class 2
Risk

K780957 is an FDA 510(k) clearance for the SET, ADMINISTRATION, MANUAL, DIALYSIS. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1978 after a review of 24 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 American Medical Products, Inc. devices

Submission Details

510(k) Number K780957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1978
Decision Date July 06, 1978
Days to Decision 24 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
106d faster than avg
Panel avg: 130d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 79
Devices cleared under the same product code (KDJ) and FDA review panel - the closest regulatory comparables to K780957.
CONTINUOUS AMBULATORY DIALYSIS (CAPD)
K791512 · Norton Performance Plastics Corp. · Feb 1980
CAPD TRANSFER SET JC9044
K792651 · Travenol Laboratories, S.A. · Feb 1980
CYCLER SETS MOD. #5C4143, 5C4144, 5C4145
K791899 · Travenol Laboratories, S.A. · Nov 1979
PERITONEAL DIALYSIS ADMIN. SET
K780082 · Physio-Control Corp. · Jan 1978
RINSE BLOCK CONNECTOR
K771482 · Quinton, Inc. · Jan 1978
PERITONEAL CYCLER & MANIFOLD SET
K772136 · Physio-Control Corp. · Dec 1977