510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K100773Substantially Equivalent

Kai Spot Model Kms 200

Kai Medical, Inc., Honolulu HI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K100773 is the FDA 510(k) clearance record for KAI SPOT MODEL KMS 200, a class II device, cleared for Kai Medical, Inc. on under FDA product code BZQ (Monitor, Breathing Frequency). FDA records list one 510(k) clearance for Kai Medical, Inc. As of , FDA records show no recalls naming K100773.

Clearance record

Decision date
Received
(97 days to decision)
Product code
BZQ Monitor, Breathing Frequency
Regulation
21 CFR 868.2375
Device class
Class II
Review panel
Anesthesiology
Applicant
Kai Medical, Inc. 3465 Waialae Ave., Honolulu HI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZQ

Trailing 12 months
2 clearances under product code BZQ in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code BZQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20260
August 20260
September 20260
October 20260