Cleared Special

K071955 - WIM-PC

K071955 is an FDA 510(k) clearance for WIM-PC, manufactured by Karmelsonix. The device is a Class 2 Anesthesiology device with product code BZM cleared through the Special 510(k) pathway after a 108-day FDA review.

K071955 · Karmelsonix · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
108d
Days
Class 2
Risk

K071955 is an FDA 510(k) clearance for the WIM-PC, MODEL 1010. 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 November 1, 2007 after a review of 108 days - within the typical 510(k) review window.

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.

View all Karmelsonix devices

FDA 510(k) Submission Details - K071955

510(k) Number K071955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2007
Decision Date November 01, 2007
Days to Decision 108 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 140d · This submission: 108d
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 9
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