# K181143: Keeler TonoCare Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Keeler Instruments, Inc.
- Decided: Feb 8, 2019 after 283 days
- Product code: HKX (Tonometer, Ac-Powered)
- 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: 2 generations back to K990257 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000, Keeler Instruments, Inc. (2010) Summary page 4.

## Indications for use
The Keeler TonoCare Tonometer is a hand-held, battery operated, non-contact tonometer intended to be used for measuring intraocular pressure (IOP) of the human eye with less than 3D in corneal astigmatism.

Source page: https://510kreport.com/device/K181143
Methodology: https://510kreport.com/methodology