Cleared Traditional

K895586 - VVR/Q CALORIMETER

K895586 is an FDA 510(k) clearance for VVR/Q CALORIMETER, manufactured by Vita-Stat. The device is a Class 2 Anesthesiology device with product code BZL cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K895586 · Vita-Stat · Anesthesiology device
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Sep 1989
Decision
7d
Days
Class 2
Risk

K895586 is an FDA 510(k) clearance for the VVR/Q CALORIMETER. Classified as Computer, Oxygen-uptake (product code BZL), Class II - Special Controls.

Submitted by Vita-Stat (Escondido, US). The FDA issued a Cleared decision on September 22, 1989 after a review of 7 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 Vita-Stat devices

FDA 510(k) Submission Details - K895586

510(k) Number K895586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 1989
Decision Date September 22, 1989
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 140d · This submission: 7d
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 18
Devices cleared under the same product code (BZL) and FDA review panel - the closest regulatory comparables to K895586.
7250 METABOLIC MONITOR
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K931422 · Datex Division Instrumentarium Corp. · Nov 1993
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