Cleared Traditional

K831780 - METABOLIC EXERCISE TESTING SYSTEM

K831780 is an FDA 510(k) clearance for METABOLIC EXERCISE TESTING SYSTEM, manufactured by Warren E. Collins, Inc.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K831780 · Warren E. Collins, Inc. · Anesthesiology device
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Sep 1983
Decision
102d
Days
Class 2
Risk

K831780 is an FDA 510(k) clearance for the METABOLIC EXERCISE TESTING SYSTEM. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Warren E. Collins, Inc. (Walker, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 102 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 Warren E. Collins, Inc. devices

FDA 510(k) Submission Details - K831780

510(k) Number K831780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1983
Decision Date September 12, 1983
Days to Decision 102 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 140d · This submission: 102d
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 17
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K831780.
MEDGRAPHICS PF/DX
K912906 · Medical Graphics Corp. · Feb 1992
DELTATRAC(TM) METABOLIC MONITOR
K864603 · Datex Division Instrumentarium Corp. · Mar 1987
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
BECKMAN MMC II METABOLIC MEAS. CART
K820905 · Beckman Instruments, Inc. · May 1982