Cleared Traditional

K905480 - SPIROSCOPE

K905480 is the FDA 510(k) clearance for SPIROSCOPE by Grandcor Medical Systems. It is a Class 2 Anesthesiology device (product code BZC) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K905480 · Grandcor Medical Systems · Anesthesiology device
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May 1991
Decision
151d
Days
Class 2
Risk

K905480 is an FDA 510(k) clearance for the SPIROSCOPE. Classified as Calculator, Pulmonary Function Data (product code BZC), Class II - Special Controls.

Submitted by Grandcor Medical Systems (Dayton, US). The FDA issued a Cleared decision on May 6, 1991 after a review of 151 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1880 - 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.

View all Grandcor Medical Systems devices

Submission Details

510(k) Number K905480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date May 06, 1991
Days to Decision 151 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BZC Calculator, Pulmonary Function Data
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1880
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 - BZC Calculator, Pulmonary Function Data

All 8
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