510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K051279Substantially Equivalent

Caldyne, Inc. Exhalometer Ex100, Model Ex100

Caldyne, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051279 is the FDA 510(k) clearance record for CALDYNE, INC. EXHALOMETER EX100, MODEL EX100, a class II device, cleared for Caldyne, Inc. on under FDA product code BZK (Spirometer, Monitoring (W/Wo Alarm)). FDA records list one 510(k) clearance for Caldyne, Inc. As of , FDA records show no recalls naming K051279.

Clearance record

Decision date
Received
(113 days to decision)
Product code
BZK Spirometer, Monitoring (W/Wo Alarm)
Regulation
21 CFR 868.1850
Device class
Class II
Review panel
Anesthesiology
Applicant
Caldyne, Inc. 29201 Via Norte, Temecula CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZK

Trailing 12 months
1 clearance under product code BZK in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BZK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260