510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K853405Substantially Equivalent

Electrolyte Analyzer Sera-252

Horiba Instruments Incorporated, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853405 is the FDA 510(k) clearance record for ELECTROLYTE ANALYZER SERA-252, a class II device, cleared for Horiba Instruments, Inc. on under FDA product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph). FDA records list 89 510(k) clearances for HORIBA INSTRUMENTS INCORPORATED, from to . As of , FDA records show no recalls naming K853405.

Clearance record

Decision date
Received
(114 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
Horiba Instruments, Inc. 1021 Duryea Ave., Irvine CA
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