Cleared Traditional

K863134 - MULTISPIRO SA/100

K863134 is an FDA 510(k) clearance for MULTISPIRO SA/100, manufactured by Biotrine Corp.. The device is a Class 2 Anesthesiology device with product code BZG cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K863134 · Biotrine Corp. · Anesthesiology device
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Dec 1986
Decision
122d
Days
Class 2
Risk

K863134 is an FDA 510(k) clearance for the MULTISPIRO SA/100. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Biotrine Corp. (Woburn, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 122 days - within the typical 510(k) review window.

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: 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.

FDA 510(k) Submission Details - K863134

510(k) Number K863134 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1986
Decision Date December 15, 1986
Days to Decision 122 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 140d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZG Device Classification - Class 2, Special Controls

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 159
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K863134.
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K881402 · American Electromedics Corp. · Sep 1988
VITALOGRAPH-ALPHA
K873562 · Vitalograph , Ltd. · Aug 1988
SPIRO ANALYZER ST-300
K873817 · Futuremed Div. of Future Impex Corp. · Dec 1987
SALTER VOLUCHEK 6600
K863656 · Salter Labs · Oct 1986
SCREENMATE
K853409 · Erich Jaeger, Inc. · Feb 1986
MODEL 2120 SPIROSCREEN
K854403 · Gould, Inc. · Jan 1986