510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K093388Substantially Equivalent

Smart Capnoline Guardian

Oridion Medical 1987 Ltd., Jerusalem, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K093388 is the FDA 510(k) clearance record for SMART CAPNOLINE GUARDIAN, a class II device, cleared for Oridion Medical 1987 , Ltd. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 19 510(k) clearances for Oridion Medical 1987 , Ltd., from to . As of , FDA records show one recall naming K093388.

Clearance record

Decision date
Received
(125 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
Oridion Medical 1987 , Ltd. 7 Hamarpe St. P.O.B. 45025, Jerusalem, IL
510(k) summary
Statement
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