510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955340Substantially Equivalent

Eurotrol Gas - Ise Control

Direct Solutions, Westford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955340 is the FDA 510(k) clearance record for EUROTROL GAS - ISE CONTROL, a class I device, cleared for Direct Solutions on under FDA product code JJS (Controls For Blood-Gases, (Assayed And Unassayed)). FDA records list 5 510(k) clearances for Direct Solutions, from to . As of , FDA records show no recalls naming K955340.

Clearance record

Decision date
Received
(36 days to decision)
Product code
JJS Controls For Blood-Gases, (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Direct Solutions 7 Hayrick Ln., Westford MA
510(k) summary
Summary
Third party review
No

Clearances, product code JJS

Trailing 12 months

FDA records hold no clearances under product code JJS in the trailing twelve months.

FDA records show no clearances under product code JJS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260