Keeler

Company overview

Keeler designs, manufactures and commercializes ophthalmic instruments and diagnostic equipment. The business traces its origins to 1917 and has its U.K. headquarters in Windsor, Berkshire.

Its device portfolio includes slit lamps, ophthalmoscopes, tonometers and ophthalmic ultrasound systems. Keeler is part of Halma; its U.S. operation is based in Malvern, Pennsylvania. This profile covers the Keeler business rather than creating a duplicate regional profile for Keeler USA.

Regulatory records retain the original legal applicant. Keeler Limited and Accutome, Inc. doing business as Keeler USA appear on different FDA filings; their records are not interchangeable with those of the Halma parent.

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Products & regulatory status How does MedTechIndex get this information?

Summary

Selected FDA records include K151394 for Keeler Slit Lamp, K133234 for T-Type and R-Type D-KAT digital applanation tonometers, and K243227 for B-Scan. The first two identify Keeler Limited; K243227 identifies Accutome, Inc. doing business as Keeler USA. ^[2][1][3]

A broader Keeler/Accutome applicant search returned additional records whose current product mappings were not fully assessed. They are not automatically added to the displayed current-portfolio count. Brand, model and legal-applicant scope remain important. ^[2][1][3]

A historical All Pupil II recall was initiated in January 2008 and terminated in August 2008. It falls outside the three selected product families and is excluded from the current-portfolio count. ^[4]

Regulatory snapshot How to read this snapshot

U.S. FDA

3+

510(k) clearances

—

De Novo grants

—

PMA approvals

—

Recall events

Latest recorded source review: 2026-10-28.

Commercial portfolio snapshot

Documented commercial product families.

Ophthalmic examination equipment

KSL-H slit lamps ↗

Slit-lamp biomicroscopes used for magnified examination of ocular structures; traditional and digital-ready configurations are listed. ^[7][2]

FDA-cleared

Listed by the company; configurations and market availability vary.

Intraocular pressure measurement

D-KAT applanation tonometers ↗

Digital applanation tonometers for measurement of intraocular pressure during ophthalmic assessment. ^[8][1]

FDA-cleared

Listed by the company; configurations and market availability vary.

Ophthalmic ultrasound imaging

B-Scan ophthalmic ultrasound ↗

Ultrasound imaging equipment used in ophthalmic examinations; B-Scan Plus is the illustrated catalog example. ^[9][3]

FDA-cleared

Listed by the company; configurations and market availability vary.