510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850197Substantially Equivalent

Keller Cephalometric Device

Gary D. Keller, Sherman TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850197 is the FDA 510(k) clearance record for KELLER CEPHALOMETRIC DEVICE, a class I device, cleared for Gary D. Keller on under FDA product code IWY (Holder, Head, Radiographic). FDA records list one 510(k) clearance for Gary D. Keller. As of , FDA records show no recalls naming K850197.

Clearance record

Decision date
Received
(63 days to decision)
Product code
IWY Holder, Head, Radiographic
Regulation
21 CFR 892.1920
Device class
Class I
Review panel
Radiology
Applicant
Gary D. Keller Grayson Bank Bldg., Sherman TX
Third party review
No

Clearances, product code IWY

Trailing 12 months

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

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