510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K962638Substantially Equivalent

Tonocap, Tc-200 and Accessory Catheters

Instrumentarium Corp., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K962638 is the FDA 510(k) clearance record for TONOCAP, TC-200 AND ACCESSORY CATHETERS, a class II device, cleared for Instrumentarium Corp. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 20 510(k) clearances for Instrumentarium Corp., from to . As of , FDA records show no recalls naming K962638.

Clearance record

Decision date
Received
(273 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
Instrumentarium Corp. 2 Highwood Dr., Tewksbury MA
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