Cleared Traditional

K842303 - MICROSPAN -PH MONITOR

K842303 is an FDA 510(k) clearance for MICROSPAN -PH MONITOR, manufactured by Biochem International, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K842303 · Biochem International, Inc. · Anesthesiology device
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Oct 1984
Decision
123d
Days
Class 2
Risk

K842303 is an FDA 510(k) clearance for the MICROSPAN -PH MONITOR. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Biochem International, Inc. (Milwaukee, US). The FDA issued a Cleared decision on October 12, 1984 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - 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 Biochem International, Inc. devices

FDA 510(k) Submission Details - K842303

510(k) Number K842303 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1984
Decision Date October 12, 1984
Days to Decision 123 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 140d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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.