# K053430: Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Xomed, Inc.
- Decided: Mar 3, 2006 after 84 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: 1 generation back to K964312 (1996). 1 ancestor in all.
9 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)
- K964312: Mentor Tono-Pen 3, Mentor Ophthalmics, Inc. (1996) Summary page 1.

## Most influential descendants
- 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
- K220852: iCare IC200 (2022), 1 descendant of its own

## Indications for use
The indications for use include measuring intraocular pressure for suspected glaucoma or when an increased intraocular pressure is suspected.

Source page: https://510kreport.com/device/K053430
Methodology: https://510kreport.com/methodology