510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954482Substantially Equivalent

Sendx 100 Ph, Blood Gas & Electrolyte Analysis System

Cirrus Medical,Inc., La Jolla CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954482 is the FDA 510(k) clearance record for SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM, a class II device, cleared for Cirrus Medical,Inc. on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list one 510(k) clearance for Cirrus Medical,Inc. As of , FDA records show no recalls naming K954482.

Clearance record

Decision date
Received
(68 days to decision)
Product code
CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Regulation
21 CFR 862.1120
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Cirrus Medical,Inc. 11077 N. Torrey Pines Rd., La Jolla CA
510(k) summary
Summary
Third party review
No

Clearances, product code CHL

Trailing 12 months
1 clearance under product code CHL in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CHL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260