Lighthouse for the Blind

Saint Louis, MO, US

LIGHTHOUSE FOR THE BLIND appears in FDA device records in Saint Louis, MO. FDA records list 2 510(k) clearances between 1992-01-15 and 1994-08-03, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 8 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 2
PMA records: 0
Recall records: 8
Registered establishments: 1

510(k) clearance history

FDA records hold 2 510(k) clearances for Lighthouse for the Blind between 1992 and 1994. The busiest year on record is 1992, with 1. The most recent is 1994, with 1.

Clearances by year, as a table

510(k) clearance decisions for Lighthouse for the Blind, by decision year
Year	Clearances
1992	1
1994	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K941869	SPLINT, PNEUMATIC, ARM & SPLINT, PNEUMATIC, LEG	KZF	Substantially Equivalent	1994-08-03
K914691	INDIVIDUAL/LARGE/BELT FIRST AID KITS	LYY	Unknown	1992-01-15

Registered establishments

FDA registered establishments for Lighthouse for the Blind, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
1925025	1000118065	LIGHTHOUSE FOR THE BLIND	10440 TRENTON AVE., Saint Louis, MO 63132 US	2026	IMD KOA LRR NAD OHO OKH

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-1093-2013	LHB, Perishable Items Pack Type IV. Kit number: 2114016-100. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1092-2013	LHB, First Aid Type IV Belt Type, NSN #6545-01-010-7754. Kit number: 114016. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1091-2013	LHB, Perishable Item Pack Type III. Kit number: 2114011-100. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1090-2013	LHB, First Aid Type III, NSN # 6545-00-656-1094, Kit number: 2114011. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1089-2013	LHB, Perishable Items Pack Type I , Kit Number: 2114002-100. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1088-2013	LHB, First Aid Type I Individual Kit, NSN: 6545-00-656-1092, antiseptics, Kit number: 2114002. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1087-2013	LHB, Antiseptic Kit, Povidone Swab, Gauze Pads, and non-stick pads. Kit Number: 2113305. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated
Z-1086-2013	LHB, Type I First Aid Kit Perishable, Non-Aspirin 4/pg, Aspirin 4/pg and Povidone Iodine, antiseptic towelette. Kit Number: 2113110. First Aid Kit.	The product contains an iodine 10% Ampule (10% Povidone Iodine swab) which is being recalled by the firm's distributor. The labeling of the iodine 10% Ampule labels state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterili	Class III	2013-03-22	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain