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
K961090Substantially Equivalent

Automatic Visual Field Plotter Ap-125

Kowa Pharmaceuticals America, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961090 is the FDA 510(k) clearance record for AUTOMATIC VISUAL FIELD PLOTTER AP-125, a class I device, cleared for Kowa Optimed, Inc. on under FDA product code HPT (Perimeter, Automatic, Ac-Powered). FDA records list 10 510(k) clearances for Kowa Pharmaceuticals America, Inc., from to . As of , FDA records show no recalls naming K961090.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HPT Perimeter, Automatic, Ac-Powered
Regulation
21 CFR 886.1605
Device class
Class I
Review panel
Ophthalmic
Applicant
Kowa Optimed, Inc. 700 Thirteenth St. N.W, Washington DC
510(k) summary
Statement
Third party review
No

Clearances, product code HPT

Trailing 12 months

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

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