Cleared Traditional

K864603 - DELTATRAC(TM) METABOLIC MONITOR

K864603 is an FDA 510(k) clearance for DELTATRAC(TM) METABOLIC MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K864603 · Datex Division Instrumentarium Corp. · Anesthesiology device
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Mar 1987
Decision
113d
Days
Class 2
Risk

K864603 is an FDA 510(k) clearance for the DELTATRAC(TM) METABOLIC MONITOR. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Melrose, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1730 - 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K864603

510(k) Number K864603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1986
Decision Date March 17, 1987
Days to Decision 113 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
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZL Device Classification - Class 2, Special Controls

Product Code BZL Computer, Oxygen-uptake
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1730
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 - BZL Computer, Oxygen-uptake

All 13
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K864603.
7250 METABOLIC MONITOR
K924978 · Puritan Bennett Corp. · Sep 1994
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · Datex Division Instrumentarium Corp. · Nov 1993
MEDGRAPHICS PF/DX
K912906 · Medical Graphics Corp. · Feb 1992
ERGO-PNEUMOTEST
K853434 · Erich Jaeger, Inc. · Feb 1986
METABOLIC MEASUREMENT CART
K822710 · Beckman Instruments, Inc. · Oct 1982
ENGSTROM METABOLIC COMPUTER
K821344 · Lkb Instruments, Inc. · May 1982