510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K953031Substantially Equivalent

Zeimer Self Tonometer

Cds Technologies, W. Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953031 is the FDA 510(k) clearance record for ZEIMER SELF TONOMETER, a class II device, cleared for Cds Technologies on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list one 510(k) clearance for Cds Technologies. As of , FDA records show no recalls naming K953031.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Cds Technologies 396 Fenton Ln., W. Chicago IL
510(k) summary
Statement
Third party review
No

Clearances, product code HKX

Trailing 12 months
1 clearance under product code HKX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260