Cleared Traditional

K812771 - PERITONEAL DIALYSIS DRAINAGE

K812771 is the FDA 510(k) clearance for PERITONEAL DIALYSIS DRAINAGE by Dravon Medical, Inc.. It is a Class 2 Gastroenterology & Urology device (product code KDJ) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K812771 · Dravon Medical, Inc. · Gastroenterology & Urology device
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Oct 1981
Decision
14d
Days
Class 2
Risk

K812771 is an FDA 510(k) clearance for the PERITONEAL DIALYSIS DRAINAGE. Classified as Set, Administration, For Peritoneal Dialysis, Disposable (product code KDJ), Class II - Special Controls.

Submitted by Dravon Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1981 after a review of 14 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 Dravon Medical, Inc. devices

Submission Details

510(k) Number K812771 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1981
Decision Date October 19, 1981
Days to Decision 14 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
116d faster than avg
Panel avg: 130d · This submission: 14d
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 K812771.
COMPACT EXCHANGE DEVICE 5C4197
K851208 · Travenol Laboratories, S.A. · Apr 1985
CARD U.V. GERMICIDAL CHAMBER II
K820546 · Travenol Laboratories, S.A. · Jun 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802 · Travenol Laboratories, S.A. · Mar 1982
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294 · Gambro, Inc. · Jun 1981
INPERSOL CAPD BAG PORT CLAMP
K803300 · Abbott Laboratories · Jan 1981
INPERSOL-CAPD ADMINISTRATION SET
K801881 · Abbott Laboratories · Oct 1980