510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901523Substantially Equivalent

Vkg 1000, Video Keratograph

The Sanborn Co., Santa Clara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901523 is the FDA 510(k) clearance record for VKG 1000, VIDEO KERATOGRAPH, a class I device, cleared for The Sanborn Co. on under FDA product code HJA (Photokeratoscope). FDA records list 2 510(k) clearances for The Sanborn Co., from to . As of , FDA records show no recalls naming K901523.

Clearance record

Decision date
Received
(86 days to decision)
Product code
HJA Photokeratoscope
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
The Sanborn Co. 5181 Lafayette St., Santa Clara CA
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