Cleared Traditional

K833826 - BTI BIOX III OXIMETER CRITICAL CAREUNI

K833826 is an FDA 510(k) clearance for BTI BIOX III OXIMETER CRITICAL CAREUNI, manufactured by Biox Technology, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K833826 · Biox Technology, Inc. · Anesthesiology device
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Dec 1983
Decision
65d
Days
Class 2
Risk

K833826 is an FDA 510(k) clearance for the BTI BIOX III OXIMETER CRITICAL CAREUNI. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Biox Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1983 after a review of 65 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.

FDA 510(k) Submission Details - K833826

510(k) Number K833826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1983
Decision Date December 30, 1983
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
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 702
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K833826.
PULSE OXIMETER
K855027 · Physio-Control Corp. · May 1986
NELLCOR PULSE OXIMETER N-10
K844256 · Nellcor, Inc. · Dec 1984
MINOLTA SM-32 OXYGEN SATURATION MONIT
K833973 · Marquest Medical Products, Inc. · May 1984
PULSE OXIMETER MODEL 100
K822909 · Nellcor, Inc. · Nov 1982
UNISTAT OXIMETER
K780625 · American Optical Corp. · Apr 1978
K833826 · BTI BIOX III OXIMETER CRITICAL CAREUNI
Download PDF Biox Technology, Inc.