Cleared Traditional

K854333 - BIOCHEM 515 RESPIRATION MONITOR

K854333 is the FDA 510(k) clearance for BIOCHEM 515 RESPIRATION MONITOR by Biochem International, Inc.. It is a Class 2 Anesthesiology device (product code BZQ) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K854333 · Biochem International, Inc. · Anesthesiology device
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May 1986
Decision
214d
Days
Class 2
Risk

K854333 is an FDA 510(k) clearance for the BIOCHEM 515 RESPIRATION MONITOR. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Biochem International, Inc. (Waukesha, US). The FDA issued a Cleared decision on May 30, 1986 after a review of 214 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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

Submission Details

510(k) Number K854333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date May 30, 1986
Days to Decision 214 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 140d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K854333.
AR-800PA RESPIRATION MODULE
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MODEL 500E INFANT MONITORING SYSTEM
K873791 · Ge Medical Systems Information Technologies · Nov 1987
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K862462 · Nihon Kohden America, Inc. · Feb 1987
NEO-TRAK 502 INFANT MONITOR
K861407 · Ge Medical Systems Information Technologies · May 1986
COROMETRICS 500 INFANT MONITOR
K850504 · Ge Medical Systems Information Technologies · Jun 1985
EEG & RESPIRATION MODULES POLYGRAPH
K823563 · Nihon Kohden America, Inc. · Jan 1983