510(k) · Cleared
ClearedIcare Tonometer TA01I
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tiolat OY · HKY Tonometer, Manual
Cleared on May 23, 2007 as substantially equivalent to K981432 (Golden Vision, Inc., 1999) and 3 other predicates after a 145-day review. Its family tree reaches back 2 generations to 1995. 8 later devices descend from it.
- Decided
- May 23, 2007
- Review
- 145 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K943939 (1995). 6 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- 1 generation backK021937 TGDC-01 PraTruevision Instruments · 2002
- This deviceK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · cites it directly · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
- Descendant · 2 generations on · 2 of its ownK190316 Icare ic200Icare Finland OY · 2020
- Descendant · cites it directly · 2 of its ownK163343 Icare HOME tonometerIcare Finland OY · 2017
- Descendant · 3 generations on · 1 of its ownK220852 iCare IC200Icare Finland OY · 2022
- Descendant · 2 generations on · 1 of its ownK200966 Icare HOME TonometerIcare Finland OY · 2020
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K153694Icare ic100Icare Finland OY · 2016 · cites it directly4descendants
- K190316Icare ic200Icare Finland OY · 2020 · 2 generations on2descendants
- K163343Icare HOME tonometerIcare Finland OY · 2017 · cites it directly2descendants
- K220852iCare IC200Icare Finland OY · 2022 · 3 generations on1descendant
- K200966Icare HOME TonometerIcare Finland OY · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| −1 | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| 0 (this device) | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +1 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| +2 | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| +1 | K163343 | Icare HOME tonometer | Icare Finland OY | 2017 | — |
| +3 | K220852 | iCare IC200 | Icare Finland OY | 2022 | — |
| +2 | K200966 | Icare HOME Tonometer | Icare Finland OY | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K981432 | Goldman Manual TonometerSummary page 2…ame: APPLANATION TONOMETER AT 900 Classification name: 86HKY Regulation number: 886.1930 Device class: Class II 510(k) number: K981432 Manufacturer: MEDTRONIC Device name: MEDTRONIC TONO-PEN XL Classification name: 86HKY Regulation numbe… | 1999 |
| * | K053430 | Tono-Pen Avia Tonometer and Ocu-Shiled Tip CoverSummary page 2…evice name: MEDTRONIC TONO-PEN XL Classification name: 86HKY Regulation number: 886.1930 Device class: Class II 510(k) number: K053430 Manufacturer: SMT SWISS MICROTECHNOLOGY AG Model name: PASCAL DYNAMIC CONTOUR TONOMETER Classification n… | 2006 |
| * | K032967 | Pascal Dynamic Contour TonometerSummary page 2…PASCAL DYNAMIC CONTOUR TONOMETER Classification name: 86HKY Regulation number: 886.1930 Device class: Class II 5 10(k) number: K032967 Manufacturer: RYAZAN STATE INSTRUMENT-MAKING ENTERPRISE Model name: Tonometer T… | 2003 |
| * | K021937 | TGDC-01 PraSummary page 2…l name: Tonometer TGDc-0 1 "PRA" Classification name: 86HKX Regulation number: 886.1930 Device class: Class II 510(k) number: K021937 10 5.4 Substantial Equivalen… | 2002 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K153694 (Icare Finland OY, 2016) has gone furthest, with 4 descendants of its own.
- 9 other devices also cite its predicate K981432.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 iCare Tonometer TA01i is intended to be used for the measurement of intraocular pressure of the human eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063873 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063873: Icare Tonometer TA01I.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063873
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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