510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K922553Substantially Equivalent

Cla-Computerized Laryngeal Analyzer

H.I.L. Research, Ltd., Chico CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922553 is the FDA 510(k) clearance record for CLA-COMPUTERIZED LARYNGEAL ANALYZER, a class II device, cleared for H.I.L. Research, Ltd. on under FDA product code KLA (Monitor, Esophageal Motility, Anorectal Motility, And Tube). FDA records list one 510(k) clearance for H.I.L. Research, Ltd. As of , FDA records show no recalls naming K922553.

Clearance record

Decision date
Received
(816 days to decision)
Product code
KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Regulation
21 CFR 876.1725
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
H.I.L. Research, Ltd. 3407 Bay Ave., Chico CA
510(k) summary
Summary
Third party review
No

Clearances, product code KLA

Trailing 12 months

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

FDA records show no clearances under product code KLA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLA, 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