Cleared Traditional

K913332 - CIBA CORNING MODEL 270 CO-OXIMETER

K913332 is an FDA 510(k) clearance for CIBA CORNING MODEL 270 CO-OXIMETER, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K913332 · Ciba Corning Diagnostics Corp. · Anesthesiology device
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Oct 1991
Decision
90d
Days
Class 2
Risk

K913332 is an FDA 510(k) clearance for the CIBA CORNING MODEL 270 CO-OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on October 23, 1991 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Ciba Corning Diagnostics Corp. devices

FDA 510(k) Submission Details - K913332

510(k) Number K913332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1991
Decision Date October 23, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K913332.
SENSORMEDICS OXYSHUTTLE II(TM)
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MODEL 8604-FO PULSE OXIMETER
K910001 · Nonin Medical, Inc. · Jul 1991
SATLITE PLUS PULSE OXIMETER
K905140 · Datex Division Instrumentarium Corp. · May 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991