Cleared Traditional

K895150 - CONTINUCATH 1000 INTRAVASCULAR OXYGEN M...

K895150 is an FDA 510(k) clearance for CONTINUCATH 1000 INTRAVASCULAR OXYGEN M..., manufactured by Shiley, Inc.. The device is a Class 2 Anesthesiology device with product code CCE cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K895150 · Shiley, Inc. · Anesthesiology device
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Nov 1989
Decision
97d
Days
Class 2
Risk

K895150 is an FDA 510(k) clearance for the CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING. Classified as Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling (product code CCE), Class II - Special Controls.

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on November 28, 1989 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1200 - 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K895150

510(k) Number K895150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1989
Decision Date November 28, 1989
Days to Decision 97 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
43d faster than avg
Panel avg: 140d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CCE Device Classification - Class 2, Special Controls

Product Code CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1200
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 - CCE Analyzer, Gas, Oxygen, Partial Pressure, Blood-phase, Indwelling

All 14
Devices cleared under the same product code (CCE) and FDA review panel - the closest regulatory comparables to K895150.
PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM
K905397 · Puritan Bennett Corp. · May 1991
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · Baxter Healthcare Corp · Dec 1989
NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY
K895149 · Shiley, Inc. · Nov 1989
BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM
K884063 · C.R. Bard, Inc. · Dec 1988
UMBILICAL ARTERY OXYGEN SENSOR
K875225 · Ohmeda Medical · Mar 1988
UMBILICAL ARTERY OXYGEN PROBE MODEL UAP-100
K872896 · American Bentley · Feb 1988