Cleared Traditional

PERITONEAL CATHETER-CHANGES- (K833749) - FDA 510(k) Clearance

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

K833749 · Quinton, Inc. · Gastroenterology & Urology device

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Dec 1983

Decision

62d

Days

Class 2

Risk

K833749 is an FDA 510(k) clearance for the PERITONEAL CATHETER-CHANGES-. Classified as System, Peritoneal, Automatic Delivery (product code FKX), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 62 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 Quinton, Inc. devices

Submission Details

510(k) Number	K833749 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 26, 1983
Decision Date	December 27, 1983
Days to Decision	62 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

68d faster than avg

Panel avg: 130d · This submission: 62d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FKX System, Peritoneal, Automatic Delivery
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 - FKX System, Peritoneal, Automatic Delivery

All 35

Devices cleared under the same product code (FKX) and FDA review panel - the closest regulatory comparables to K833749.

SCD STERILE CONNECTION DEVICE

K844144 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1984

EXTENDED LIFE CAPD SOLUTION TRANSFER

K842885 · Travenol Laboratories, S.A. · Oct 1984

EXTENDED LIFE CAPD SOLUTION TRANSFER

K840224 · Travenol Laboratories, S.A. · Feb 1984

CAPD ULTRAVIOLET GERMICIDAL EXCHANGE

K833595 · Travenol Laboratories, S.A. · Nov 1983

AUTOMATIC PERITONEAL DIALYSIS CYCLER

K833065 · Travenol Laboratories, S.A. · Nov 1983

ABBOTT PATIENT ASSIST DEVICE

K830766 · Abbott Laboratories · Mar 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K833749

Quinton, Inc.

Mchenry, IL · US

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Gastroenterology & Urology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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