Cleared Traditional

K911358 - CMD/DLCO DIAGNOSTIC SPIROMETER

K911358 is an FDA 510(k) clearance for CMD/DLCO DIAGNOSTIC SPIROMETER, manufactured by Spirometrics, Inc.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K911358 · Spirometrics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
116d
Days
Class 2
Risk

K911358 is an FDA 510(k) clearance for the CMD/DLCO DIAGNOSTIC SPIROMETER. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Spirometrics, Inc. (Auburn, US). The FDA issued a Cleared decision on July 22, 1991 after a review of 116 days - within the typical 510(k) review window.

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: 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 Spirometrics, Inc. devices

FDA 510(k) Submission Details - K911358

510(k) Number K911358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date July 22, 1991
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
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.

Regulatory Peers - BTY Calculator, Predicted Values, Pulmonary Function

All 39
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K911358.
UPGRADED SPIROMETER ST-90
K933511 · Futuremed Div. of Future Impex Corp. · Feb 1994
MODEL 508 PATIENT MONITOR
K921309 · Criticare Systems, Inc. · Dec 1993
VITALOGRAPH DATA STORAGE SPIROMETER
K930085 · Vitalograph , Ltd. · Jul 1993
L.A.P. SPIROMETER
K864836 · Timeter Instrument Corp. · Mar 1987
SPIROMETRY MODULE
K861486 · Medical Graphics Corp. · May 1986
VITALOGRAPH PFT PRINTER
K823683 · Vitalograph , Ltd. · Jan 1983