Cleared Traditional

K822710 - METABOLIC MEASUREMENT CART

K822710 is an FDA 510(k) clearance for METABOLIC MEASUREMENT CART, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K822710 · Beckman Instruments, Inc. · Anesthesiology device
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Oct 1982
Decision
36d
Days
Class 2
Risk

K822710 is an FDA 510(k) clearance for the METABOLIC MEASUREMENT CART. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 13, 1982 after a review of 36 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K822710

510(k) Number K822710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1982
Decision Date October 13, 1982
Days to Decision 36 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
104d faster than avg
Panel avg: 140d · This submission: 36d
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 9
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K822710.
DELTATRAC(TM) II METABOLIC MONITOR
K931422 · Datex Division Instrumentarium Corp. · Nov 1993
DELTATRAC(TM) METABOLIC MONITOR
K864603 · Datex Division Instrumentarium Corp. · Mar 1987
ERGO-PNEUMOTEST
K853434 · Erich Jaeger, Inc. · Feb 1986
ENGSTROM METABOLIC COMPUTER
K821344 · Lkb Instruments, Inc. · May 1982
BECKMAN MMC II METABOLIC MEAS. CART
K820905 · Beckman Instruments, Inc. · May 1982
AB O2 CONSUMPTION CALCULATOR 980
K802417 · Siemens Elema AB · Oct 1980