510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862559Substantially Equivalent

Carbostat, CO2 Analyzer

Elm Street Designs, San Carlos CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862559 is the FDA 510(k) clearance record for CARBOSTAT, CO2 ANALYZER, a class II device, cleared for Elm Street Designs on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list one 510(k) clearance for Elm Street Designs. As of , FDA records show no recalls naming K862559.

Clearance record

Decision date
Received
(12 days to decision)
Product code
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Regulation
21 CFR 868.1400
Device class
Class II
Review panel
Anesthesiology
Applicant
Elm Street Designs 520 Elm St., #2, San Carlos CA
Third party review
No

Clearances, product code CCK

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