Cleared Traditional

ACUTE PERITONEAL DIALYSIS CATHETERS (K854966) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K854966 · Thermedics, Inc. · Gastroenterology & Urology device
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Jan 1986
Decision
29d
Days
Class 2
Risk

K854966 is an FDA 510(k) clearance for the ACUTE PERITONEAL DIALYSIS CATHETERS. Classified as Catheter, Peritoneal Dialysis, Single Use (product code FKO), Class II - Special Controls.

Submitted by Thermedics, Inc. (Woburn, US). The FDA issued a Cleared decision on January 9, 1986 after a review of 29 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 Thermedics, Inc. devices

Submission Details

510(k) Number K854966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date January 09, 1986
Days to Decision 29 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
101d faster than avg
Panel avg: 130d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FKO Catheter, Peritoneal Dialysis, Single Use
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 - FKO Catheter, Peritoneal Dialysis, Single Use

Devices cleared under the same product code (FKO) and FDA review panel - the closest regulatory comparables to K854966.
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650 · Quinton, Inc. · Dec 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730 · Quinton, Inc. · May 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472 · Quinton, Inc. · Feb 1987
CAPD STAGED CONNECTOR
K845041 · Abbott Laboratories · Feb 1985
CATHETER, PERITONEAL DIALYSIS
K760544 · Travenol Laboratories, S.A. · Oct 1976