Cleared Traditional

K920082 - BIOCHEM MODEL 3301 NEWOX1 OXIMETER

K920082 is the FDA 510(k) clearance for BIOCHEM MODEL 3301 NEWOX1 OXIMETER by Biochem International, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K920082 · Biochem International, Inc. · Anesthesiology device
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Jan 1993
Decision
366d
Days
Class 2
Risk

K920082 is an FDA 510(k) clearance for the BIOCHEM MODEL 3301 NEWOX1 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 January 7, 1993 after a review of 366 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Biochem International, Inc. devices

Submission Details

510(k) Number K920082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1992
Decision Date January 07, 1993
Days to Decision 366 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
226d slower than avg
Panel avg: 140d · This submission: 366d
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.

Regulatory Peers - DQA Oximeter

All 249
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K920082.
OHMEDA HAND HELD OXIMETER
K931304 · Ohmeda Medical · Sep 1994
OXISAT
K934091 · Marquette Electronics, Inc. · Mar 1994
HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER
K923343 · Hewlett-Packard Co. · Feb 1993
MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE
K923682 · Hewlett-Packard Co. · Sep 1992
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991
AP-860PA NIBP MODULE
K910629 · Nihon Kohden America, Inc. · May 1991