510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941869Substantially Equivalent

Splint, Pneumatic, Arm & Splint, Pneumatic, Leg

Lighthouse for the Blind, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941869 is the FDA 510(k) clearance record for SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG, a class I device, cleared for The Lighthouse For the Blind, Inc. on under FDA product code KZF (Device, Medical Examination, Ac Powered). FDA records list 2 510(k) clearances for The Lighthouse For the Blind, Inc., from to . As of , FDA records show no recalls naming K941869.

Clearance record

Decision date
Received
(107 days to decision)
Product code
KZF Device, Medical Examination, Ac Powered
Regulation
21 CFR 880.6320
Device class
Class I
Review panel
General Hospital
Applicant
The Lighthouse For the Blind, Inc. 2501 S. Plum St., Seattle WA
510(k) summary
Summary
Third party review
No

Clearances, product code KZF

Trailing 12 months

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

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