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
K861063Substantially Equivalent

Nidek Km-800 Auto Keratometer

Nidek, Inc., Palo Alto CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861063 is the FDA 510(k) clearance record for NIDEK KM-800 AUTO KERATOMETER, a class I device, cleared for Nidek, Inc. on under FDA product code HLQ (Keratoscope, Ac-Powered). FDA records list 32 510(k) clearances for Nidek, Inc., from to . As of , FDA records show no recalls naming K861063.

Clearance record

Decision date
Received
(15 days to decision)
Product code
HLQ Keratoscope, Ac-Powered
Regulation
21 CFR 886.1350
Device class
Class I
Review panel
Ophthalmic
Applicant
Nidek, Inc. 2460 Embarcadero Way, Palo Alto CA
Third party review
No

Clearances, product code HLQ

Trailing 12 months

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

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