Cleared Traditional

K870163 - BIOCHEM MICROSPAN 1040 OXIMETER

K870163 is the FDA 510(k) clearance for BIOCHEM MICROSPAN 1040 OXIMETER by Biochem International, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K870163 · Biochem International, Inc. · Anesthesiology device
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Mar 1987
Decision
48d
Days
Class 2
Risk

K870163 is an FDA 510(k) clearance for the BIOCHEM MICROSPAN 1040 OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Biochem International, Inc. (Waukesha, US). The FDA issued a Cleared decision on March 3, 1987 after a review of 48 days - a notably fast clearance cycle.

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: 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 Biochem International, Inc. devices

Submission Details

510(k) Number K870163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1987
Decision Date March 03, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.