510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021937Substantially Equivalent

Tgdc-01 Pra

Truevision Instruments, San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021937 is the FDA 510(k) clearance record for TGDC-01 PRA, a class II device, cleared for Truevision Instruments on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list one 510(k) clearance for Truevision Instruments. As of , FDA records show no recalls naming K021937.

Clearance record

Decision date
Received
(121 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Truevision Instruments 4220 Cesar Chavez #536, San Francisco CA
510(k) summary
Summary PDF
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