Cleared Special

K100773 - KAI SPOT MODEL KMS 200

K100773 is an FDA 510(k) clearance for KAI SPOT MODEL KMS 200, manufactured by Kai Medical, Inc.. The device is a Class 2 Anesthesiology device with product code BZQ cleared through the Special 510(k) pathway after a 97-day FDA review.

K100773 · Kai Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
97d
Days
Class 2
Risk

K100773 is an FDA 510(k) clearance for the KAI SPOT MODEL KMS 200. Classified as Monitor, Breathing Frequency (product code BZQ), Class II - Special Controls.

Submitted by Kai Medical, Inc. (Honolulu, US). The FDA issued a Cleared decision on June 23, 2010 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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 - K100773

510(k) Number K100773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2010
Decision Date June 23, 2010
Days to Decision 97 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
43d faster than avg
Panel avg: 140d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

BZQ Device Classification - Class 2, Special Controls

Product Code BZQ Monitor, Breathing Frequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 - BZQ Monitor, Breathing Frequency

All 119
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K100773.
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PNEUMOTHERML, MODEL: 5800
K092685 · Salter Labs · Nov 2009
KAI SENSORS NON-CONTACT RESPIRATORY RATE SPOT CHECK, MODEL 100, KAI RSPOT, MODEL 100
K090273 · Kai Sensors, Inc. · Jun 2009
K100773 · KAI SPOT MODEL KMS 200
Download PDF FDA Summary Kai Medical, Inc.