510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822917Substantially Equivalent

Model 5400 Optokinetic Stimulator

Life-Tech Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822917 is the FDA 510(k) clearance record for MODEL 5400 OPTOKINETIC STIMULATOR, a class I device, cleared for Life-Tech Intl., Inc. on under FDA product code HOW (Drum, Opticokinetic). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K822917.

Clearance record

Decision date
Received
(31 days to decision)
Product code
HOW Drum, Opticokinetic
Regulation
21 CFR 886.1200
Device class
Class I
Review panel
Ophthalmic
Applicant
Life-Tech Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOW

Trailing 12 months

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

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