Cleared Traditional

K920083 - BIOCHEM MODEL 3302 NEWOX2 OXIMETER

K920083 is an FDA 510(k) clearance for BIOCHEM MODEL 3302 NEWOX2 OXIMETER, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 825-day FDA review.

K920083 · Biochem International, Inc. · Anesthesiology device
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Apr 1994
Decision
825d
Days
Class 2
Risk

K920083 is an FDA 510(k) clearance for the BIOCHEM MODEL 3302 NEWOX2 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 April 11, 1994 after a review of 825 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Biochem International, Inc. devices

FDA 510(k) Submission Details - K920083

510(k) Number K920083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1992
Decision Date April 11, 1994
Days to Decision 825 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
685d slower than avg
Panel avg: 140d · This submission: 825d
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 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K920083.
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OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
NONIN MEDICAL, INC. FINGER PHANTOM FOR PULSE OXIMETERS
K940463 · Nonin Medical, Inc. · Mar 1994