# K152644: Keeler Disposable Tonomate, Keeler Disposable Tonomate, Box of 100

- Pathway: 510(k) (Special)
- Applicant: Keeler Limited
- Decided: Dec 31, 2015 after 106 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K981432 (1999). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093445: Keeler Applanation Tonometer; T-Type Kat, K-Type Kat, (Kat), Keeler, Ltd. (2010) Summary page 5.
- K133234: T-Type D-Kat, R-Type D-Kat, Keeler Limited (2014) Summary page 5.
- K142179: D-Kat Z-Ype, Keeler, Ltd. (2014) Summary page 6.

## Indications for use
The Keeler Applanation Tonometer and Digital Keeler Applanation Tonometer are indicated for measuring intraocular pressure to aid in the screening and diagnosis of Glaucoma.

Source page: https://510kreport.com/device/K152644
Methodology: https://510kreport.com/methodology