510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964961Substantially Equivalent

Model 405T with Etco2 Option

Ivy Biomedical Systems, Inc., Branford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964961 is the FDA 510(k) clearance record for MODEL 405T WITH ETCO2 OPTION, a class II device, cleared for Ivy Biomedical Systems, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 27 510(k) clearances for Ivy Biomedical Systems, Inc., from to . As of , FDA records show no recalls naming K964961.

Clearance record

Decision date
Received
(154 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
Ivy Biomedical Systems, Inc. 11 Business Park Dr., Branford CT
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