510(k) · Cleared
ClearedTono-Pen Avia Tonometer and Ocu-Shiled Tip Cover
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Xomed, Inc. · HKY Tonometer, Manual
Cleared on Mar 3, 2006 as substantially equivalent to K964312 (Mentor Ophthalmics, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 9 later devices descend from it.
- Decided
- Mar 3, 2006
- Review
- 84 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K964312 (1996). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964312 Mentor Tono-Pen 3Mentor Ophthalmics, Inc. · 1996
- This deviceK053430 Tono-Pen Avia Tonometer and Ocu-Shiled Tip CoverMedtronic Xomed, Inc. · 2006
- Descendant · cites it directly · 8 of its ownK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · 2 generations on · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
- Descendant · 3 generations on · 2 of its ownK190316 Icare ic200Icare Finland OY · 2020
- Descendant · 2 generations on · 2 of its ownK163343 Icare HOME tonometerIcare Finland OY · 2017
- Descendant · 4 generations on · 1 of its ownK220852 iCare IC200Icare Finland OY · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K063873Icare Tonometer TA01ITiolat OY · 2007 · cites it directly8descendants
- K153694Icare ic100Icare Finland OY · 2016 · 2 generations on4descendants
- K190316Icare ic200Icare Finland OY · 2020 · 3 generations on2descendants
- K163343Icare HOME tonometerIcare Finland OY · 2017 · 2 generations on2descendants
- K220852iCare IC200Icare Finland OY · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964312 | Mentor Tono-Pen 3 | Mentor Ophthalmics, Inc. | 1996 | — |
| 0 (this device) | K053430 | Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover | Medtronic Xomed, Inc. | 2006 | — |
| +1 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +2 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| +3 | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| +2 | K163343 | Icare HOME tonometer | Icare Finland OY | 2017 | — |
| +4 | K220852 | iCare IC200 | Icare Finland OY | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKY device
- #1 K241447 iCare ST500 (TA04)score 9.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964312 | Mentor Tono-Pen 3Summary page 1…, Product Code HKY) Marketed device claiming equivalence to The Tono-Pen AVIA with Ocu-Shield is equivalent to the Mentor Tono-Pen 3, K964312. The accessory tip cover is similar to the Oculab Ocu-Film tip cover, K882750. The current Medtronic Xomed tonometer is… | 1996 |
| † | K882750 | Ocu-Film Tip Cover | 1988 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063873 | Icare Tonometer TA01I | 2007 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K063873 (Tiolat OY, 2007) has gone furthest, with 8 descendants of its own.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HKY
128in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKY
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKY
1in 2019
MAUDE reports naming product code HKY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 123 | 2 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 226 | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 77 | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 128 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The indications for use include measuring intraocular pressure for suspected glaucoma or
when an increased intraocular pressure is suspected.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053430: Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053430
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026