# K964312: Mentor Tono-Pen 3

- Pathway: 510(k) (Traditional)
- Applicant: Mentor Ophthalmics, Inc.
- Decided: Nov 26, 1996 after 28 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
No predicates in its family tree.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Mentor Tono-Pen XL: named in the summary without a submission number

## Most influential descendants
- K053430: Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover (2006), 9 descendants of its own
- K063873: Icare Tonometer TA01I (2007), 8 descendants of its own
- K153694: Icare ic100 (2016), 4 descendants of its own
- K190316: Icare ic200 (2020), 2 descendants of its own
- K163343: Icare HOME tonometer (2017), 2 descendants of its own

## Indications for use
The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.

Source page: https://510kreport.com/device/K964312
Methodology: https://510kreport.com/methodology