510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893968Substantially Equivalent

Vkg 2000 Video Keratometer

Technitex, Inc., Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893968 is the FDA 510(k) clearance record for VKG 2000 VIDEO KERATOMETER, a class I device, cleared for Technitex, Inc. on under FDA product code HJA (Photokeratoscope). FDA records list 3 510(k) clearances for Technitex, Inc., from to . As of , FDA records show no recalls naming K893968.

Clearance record

Decision date
Received
(101 days to decision)
Product code
HJA Photokeratoscope
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Technitex, Inc. 11211 Richmond Ave., Suite, Houston TX
Third party review
No

Clearances, product code HJA

Trailing 12 months

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

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