Cleared Special

K102229 - PULMOTRACK 2020 SYSTEM

K102229 is an FDA 510(k) clearance for PULMOTRACK 2020 SYSTEM, manufactured by Karmelsonix. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Special 510(k) pathway after a 207-day FDA review.

K102229 · Karmelsonix · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
207d
Days
Class 2
Risk

K102229 is an FDA 510(k) clearance for the PULMOTRACK 2020 SYSTEM. Classified as Calculator, Pulmonary Function Interpretor (diagnostic) (product code BZM), Class II - Special Controls.

Submitted by Karmelsonix (Binyamina, IL). The FDA issued a Cleared decision on March 4, 2011 after a review of 207 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1900 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102229

510(k) Number K102229 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date March 04, 2011
Days to Decision 207 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 140d · This submission: 207d
Pathway characteristics
Modification to existing cleared device.

BZM Device Classification - Class 2, Special Controls

Product Code BZM Calculator, Pulmonary Function Interpretor (diagnostic)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1900
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 - BZM Calculator, Pulmonary Function Interpretor (diagnostic)

All 15
Devices cleared under the same product code (BZM) and FDA review panel - the closest regulatory comparables to K102229.
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