510(k) · Cleared
ClearedTGDC-01 Pra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Truevision Instruments · HKX Tonometer, Ac-Powered
Cleared on Oct 11, 2002 as substantially equivalent to K981432 (Golden Vision, Inc., 1999) and 1 other predicate after a 121-day review. Its family tree reaches back 1 generation to 1995. 11 later devices descend from it.
- Decided
- Oct 11, 2002
- Review
- 121 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K943939 (1995). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943939 Non-Contact Tonometer T-2Canon, Inc. · 1995
- This deviceK021937 TGDC-01 PraTruevision Instruments · 2002
- 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 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · 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 | K943939 | Non-Contact Tonometer T-2 | Canon, Inc. | 1995 | — |
| 0 (this device) | K021937 | TGDC-01 Pra | Truevision Instruments | 2002 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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 HKX? 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 HKX device
- #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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…51O(k) Number: produced by GOLDEN VISION, INC. K981432 7436 S.W. 117TH AVE. ,SUITE 103 MIAMI, FL 33183 3816… | 1999 |
| * | K943939 | Non-Contact Tonometer T-2Summary page 2…51O(k) Number: CANON, INC. 30-2 K943939 SHIMOMARUKO 3-CHOME OHTA-KU, TOKYO,… | 1995 |
What descends from it? (11)
See all 112 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?
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKX
290in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKX
No recall names HKX since 2007.
Adverse event reports per year · HKX
1in 2015
MAUDE reports naming product code HKX, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 290 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Quick and accurate measurement of IOP in various situations independent of place and time is the dream of every ophthalmologist. Today the portable tonometer TGDc-01 “PRA gives you that capability. This new IOP measuring method through the eyelid in the sclera area, unique to our device, eliminates completely any effect on the mucous eye membrane.
Painless diagnosticswithout anesthetics and antiseptics
Elimination of infection risk
Measuring results independent of cornea’s crookedness
Evaluation of IOP in patients after any operations on cornea
IOP measurement in children
Monitoring of Glaucoma treatment
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021937 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021937: TGDC-01 Pra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021937
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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