Cleared Traditional

K851277 - MICROSPIRO-SDS

K851277 is an FDA 510(k) clearance for MICROSPIRO-SDS, manufactured by Medical Equipment Designs, Inc.. The device is a Class 2 Anesthesiology device with 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

FDA 510(k) Submission Details - K851277

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.

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 126
Devices cleared under the same product code (BZG) and FDA review panel - the closest regulatory comparables to K851277.
PNEUMOSCOPE
K852337 · Erich Jaeger, Inc. · Jul 1985
ST-460 SPIRO ANALYZER SPIROMETER
K852308 · Futuremed Div. of Future Impex Corp. · Jun 1985
SPIROMED 2
K851620 · Draeger Medical, Inc. · May 1985
ERGO-OXYSCREEN
K843841 · Erich Jaeger, Inc. · Dec 1984
PULMONARY FUNCTION SYSTEM
K842041 · Sensor Medics Corp. · Jun 1984
RESPIRODYNE PULMONARY FUNCTION TEST
K834475 · Chesebrough-Pond'S U.S.A. Co. · Feb 1984