510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980384Substantially Equivalent

Trip Tonometry Catheter, 18F

Datex-Engstrom, Inc., Tewksbury MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980384 is the FDA 510(k) clearance record for TRIP TONOMETRY CATHETER, 18F, a class II device, cleared for Datex-Engstrom, Inc. on under FDA product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). FDA records list 10 510(k) clearances for Datex-Engstrom, Inc., from to . As of , FDA records show no recalls naming K980384.

Clearance record

Decision date
Received
(88 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
Datex-Engstrom, Inc. 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