Keeler Applanation Tonometer +1 more model
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Keeler Ltd
Identifiers
- 510(k) Number
- K093445 FDA 510(k)
- FDA Product Code
- HKY FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Keeler Applanation Tonometer (KAT) is a manual applanation tonometer designed to measure intraocular pressure (IOP) using the Goldmann applanation method. It is classified as a device for ophthalmic use, specifically for assessing glaucoma risk by quantifying IOP in the anterior chamber of the eye.
This device is supplied as a reusable, non-sterile, mechanical instrument intended for use in ophthalmic settings with compatible slit lamps. It is compatible with H-style slit lamps featuring tower illumination and can be mounted with a guide plate for removable installation. The KAT is authorised under FDA 510K and MDD regulations, adhering to Class II medical device standards for ophthalmic applications.
Frequently asked questions
Is the Keeler Applanation Tonometer (KAT) designed for single-use or can it be reused in a clinical setting?
The Keeler Applanation Tonometer (KAT) is explicitly described as a reusable mechanical instrument for ophthalmic use. It is not sterile as supplied, so it must be cleaned and maintained according to standard clinical protocols before each use in a slit-lamp setting.
What types of slit lamps is the KAT compatible with, and how is it installed?
The KAT is designed for use with H-style slit lamps that feature tower illumination. It is mounted using a guide plate for removable installation, allowing flexibility in setup depending on the clinical environment.
What regulatory pathways has the Keeler Applanation Tonometer followed for approval?
The KAT has been authorized under FDA 510(k) clearance and the MDD (Medical Device Directive) in Europe. It is classified as a Class II medical device for ophthalmic applications, adhering to the relevant regulatory standards for intraocular pressure measurement.
Are there different models of the Keeler Applanation Tonometer, and if so, what distinguishes them?
Yes, the KAT comes in two primary models: the T-Type KAT and the K-Type KAT. While the exact functional differences between these models are not detailed in the data, they are both designed for the same core purpose—measuring intraocular pressure using the Goldmann applanation method—while being compatible with H-style slit lamps.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: KAT (T-Type) - Keeler Applanation Tonometer, KAT (T-Type) applanation tonometer - Keeler, KAT (T-Type) - Keeler Applanation Tonometer
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K093445 | Class II | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- FDA Applicant
- Keeler, Ltd.
Sources (2)
- FDA 510(k) K093445 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026