510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K040011Substantially Equivalent

Polaris 2004 Capnograph

Oridion, Ltd., Needham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040011 is the FDA 510(k) clearance record for POLARIS 2004 CAPNOGRAPH, a class II device, cleared for Oridion , Ltd. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list one 510(k) clearance for Oridion , Ltd. As of , FDA records show no recalls naming K040011.

Clearance record

Decision date
Received
(129 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 , Ltd. 21 Highland Cir., Needham MA
510(k) summary
Summary PDF
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