Cleared Traditional

K810712 - ELECTRONIC SPIROMETER MODEL MFR-8100

K810712 is an FDA 510(k) clearance for ELECTRONIC SPIROMETER MODEL MFR-8100, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K810712 · Nihon Kohden America, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
7d
Days
Class 2
Risk

K810712 is an FDA 510(k) clearance for the ELECTRONIC SPIROMETER MODEL MFR-8100. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Foothill, US). The FDA issued a Cleared decision on March 24, 1981 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K810712

510(k) Number K810712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1981
Decision Date March 24, 1981
Days to Decision 7 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 140d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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.