Cleared Traditional

K801679 - BETA-CAP II

K801679 is the FDA 510(k) clearance for BETA-CAP II by Quinton, Inc.. It is a Class 2 Gastroenterology & Urology device (product code FJS) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K801679 · Quinton, Inc. · Gastroenterology & Urology device

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Oct 1980

Decision

73d

Days

Class 2

Risk

K801679 is an FDA 510(k) clearance for the BETA-CAP II. Classified as Catheter, Peritoneal, Long-term Indwelling (product code FJS), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 3, 1980 after a review of 73 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	K801679 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 22, 1980
Decision Date	October 03, 1980
Days to Decision	73 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

57d faster than avg

Panel avg: 130d · This submission: 73d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	FJS Catheter, Peritoneal, Long-term Indwelling
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 - FJS Catheter, Peritoneal, Long-term Indwelling

All 18

Devices cleared under the same product code (FJS) and FDA review panel - the closest regulatory comparables to K801679.

TENCKHOFF PERITONEAL CATHETERS

K812607 · Quinton, Inc. · Oct 1981

MIROMED PERITONEAL DIALYSIS CATHETER

K810236 · American Medical Products, Inc. · Mar 1981

TENCKHOFF CATHETER

K801818 · Sil-Med Corp. · Oct 1980

BETA CAP SYSTEM

K780449 · Quinton, Inc. · May 1978

SHADOW-CATHS

K780643 · Quinton, Inc. · Apr 1978

BETA-CAP

K771420 · Quinton, Inc. · Nov 1977

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 K801679

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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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

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