Cleared Traditional

K895779 - MODIFIED PERMCATH TRAY (2ND SUBMISSION)

K895779 is an FDA 510(k) clearance for MODIFIED PERMCATH TRAY (2ND SUBMISSION), manufactured by Quinton, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K895779 · Quinton, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
91d
Days
Class 2
Risk

K895779 is an FDA 510(k) clearance for the MODIFIED PERMCATH TRAY (2ND SUBMISSION). Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on December 7, 1989 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - the FDA anesthesiology and respiratory 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Quinton, Inc. devices

FDA 510(k) Submission Details - K895779

510(k) Number K895779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1989
Decision Date December 07, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - CBK Ventilator, Continuous, Facility Use

All 398
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K895779.
TYPE 9290 INTERFACE RESPIRATOR
K896735 · S & W Medico Teknik · Feb 1990
TYPE 9291 INTERFACE RESPIRATOR
K896736 · S & W Medico Teknik · Feb 1990
8400ST VOLUME VENTILATOR
K894322 · Bird Products Corp. · Jan 1990
PURITAN-BENNETT 7200SPI MICROPROCESSOR VENTILATOR
K893043 · Puritan Bennett Corp. · Aug 1989
NEWPORT VENTILATOR MODEL E150
K883809 · Newport Medical Instruments, Inc. · Jun 1989
ADVENT VENTILATOR
K884793 · Ohmeda Medical · Jun 1989