Cleared Traditional

K051279 - CALDYNE, INC. EXHALOMETER EX100, MODEL EX100

K051279 is an FDA 510(k) clearance for CALDYNE, manufactured by Caldyne, Inc.. The device is a Class 2 General Hospital device with product code BZK cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K051279 · Caldyne, Inc. · General Hospital
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Sep 2005
Decision
113d
Days
Class 2
Risk

K051279 is an FDA 510(k) clearance for the CALDYNE, INC. EXHALOMETER EX100, MODEL EX100. Classified as Spirometer, Monitoring (w/wo Alarm) (product code BZK), Class II - Special Controls.

Submitted by Caldyne, Inc. (Temecula, US). The FDA issued a Cleared decision on September 7, 2005 after a review of 113 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.1850 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Caldyne, Inc. devices

FDA 510(k) Submission Details - K051279

510(k) Number K051279 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2005
Decision Date September 07, 2005
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZK Device Classification - Class 2, Special Controls

Product Code BZK Spirometer, Monitoring (w/wo Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1850
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 General Hospital devices follow this clearance model.

Regulatory Peers - BZK Spirometer, Monitoring (w/wo Alarm)

All 31
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