Cleared Traditional

K895375 - MULTISPIRO

K895375 is the FDA 510(k) clearance for MULTISPIRO by Medical Equipment Designs, Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895375 · Medical Equipment Designs, Inc. · Anesthesiology device
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Nov 1989
Decision
89d
Days
Class 2
Risk

K895375 is an FDA 510(k) clearance for the MULTISPIRO. Classified as Spirometer, Diagnostic (product code BZG), Class II - Special Controls.

Submitted by Medical Equipment Designs, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on November 27, 1989 after a review of 89 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 Medical Equipment Designs, Inc. devices

Submission Details

510(k) Number K895375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date November 27, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 140d · This submission: 89d
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 30
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