Cleared Traditional

K851277 - MICROSPIRO-SDS

K851277 is the FDA 510(k) clearance for MICROSPIRO-SDS by Medical Equipment Designs, Inc.. It is a Class 2 Anesthesiology device (product code BZG) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K851277 · Medical Equipment Designs, Inc. · Anesthesiology device
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Apr 1985
Decision
18d
Days
Class 2
Risk

K851277 is an FDA 510(k) clearance for the MICROSPIRO-SDS. 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 April 19, 1985 after a review of 18 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 K851277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1985
Decision Date April 19, 1985
Days to Decision 18 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d faster than avg
Panel avg: 140d · This submission: 18d
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.