Cleared Traditional

K862023 - SPIROMATE AS-600

K862023 is the FDA 510(k) clearance for SPIROMATE AS-600 by Riko Medical & Scientific Instrument Corp.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K862023 · Riko Medical & Scientific Instrument Corp. · Anesthesiology device
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Jun 1986
Decision
20d
Days
Class 2
Risk

K862023 is an FDA 510(k) clearance for the SPIROMATE AS-600. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Riko Medical & Scientific Instrument Corp. (Lake Success, US). The FDA issued a Cleared decision on June 17, 1986 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1840 - 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 Riko Medical & Scientific Instrument Corp. devices

Submission Details

510(k) Number K862023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1986
Decision Date June 17, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 140d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZG Spirometer, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1840
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 - BZG Spirometer, Diagnostic

All 34
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K862023.
MODIFIED SPIROSCAN 1000
K897094 · Fukuda Denshi USA, Inc. · Jan 1990
PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
K895253 · Welch Allyn, Inc. · Nov 1989
PURITAN BENNETT PB900A DIAGNOSTIC SPIROMETER
K890522 · Puritan Bennett Corp. · Apr 1989
PB900 PB910 DIAGNOSTIC SPIROMETER
K852092 · Puritan Bennett Corp. · Jul 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985
BREATH METER
K810437 · Fred Sammons, Inc. · May 1981