Cleared Special

KAI SPOT MODEL KMS 200 (K100773) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K100773 · Kai Medical, Inc. · Anesthesiology device
Download Printable Device Report (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.

View all Kai Medical, Inc. devices

Submission Details

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.

Device Classification

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 36
Devices cleared under the same product code (BZQ) and FDA review panel - the closest regulatory comparables to K100773.
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COROMETRICS MODEL 510 AND 511 MONITOR
K962781 · Ge Medical Systems Information Technologies · Mar 1997
MODEL 510 INFANT MONITOR
K943308 · Ge Medical Systems Information Technologies · Jul 1995