510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K964338Substantially Equivalent

Ri-Tiniscope-Slit/ri-Tiniscope Spot/ri-Vision-Slit/ri-Vision-Spot

Rudolf Riester GmbH & Co. KG, D-72417 Jungingen, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964338 is the FDA 510(k) clearance record for RI-TINISCOPE-SLIT/RI-TINISCOPE SPOT/RI-VISION-SLIT/RI-VISION-SPOT, a class I device, cleared for Rudolf Riester GmbH & Co. KG on under FDA product code HKM (Retinoscope, Battery-Powered). FDA records list 30 510(k) clearances for Rudolf Riester GmbH & Co. KG, from to . As of , FDA records show no recalls naming K964338.

Clearance record

Decision date
Received
(70 days to decision)
Product code
HKM Retinoscope, Battery-Powered
Regulation
21 CFR 886.1780
Device class
Class I
Review panel
Ophthalmic
Applicant
Rudolf Riester GmbH & Co. KG Postfach 35, D-72417 Jungingen, DE
510(k) summary
Statement
Third party review
No

Clearances, product code HKM

Trailing 12 months

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

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