510(k) · Cleared
ClearedMiiS Horus Scope DPT 100
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimaging Integrated Solution, Inc (Miis) · HKX Tonometer, Ac-Powered
Cleared on Jun 21, 2019 as substantially equivalent to K013259 (Leica Microsystems, Inc. O.I.D., 2002) and 1 other predicate after a 406-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.
- Decided
- Jun 21, 2019
- Review
- 406 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K871335 (1987). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK871335 Topcon Computerized Tonometer CT-10Topcon Instrument Corporation of America · 1987
- This deviceK181260 MiiS Horus Scope DPT 100Medimaging Integrated Solution, Inc (Miis) · 2019
- Descendant · cites it directly · 0 of its ownK223739 VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K223739VS Tabletop TonometerMedimaging Integrated Solution, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K871335 | Topcon Computerized Tonometer CT-10 | Topcon Instrument Corporation of America | 1987 | — |
| 0 (this device) | K181260 | MiiS Horus Scope DPT 100 | Medimaging Integrated Solution, Inc (Miis) | 2019 | — |
| +1 | K223739 | VS Tabletop Tonometer | Medimaging Integrated Solution, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K013259 | Portable Non-Contact Tonometer, Model PT100Summary page 5…me MiiS Horus Scope DPT 100 Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: Class II Product Code: HKX Predicate Device: K013259 Trade/Device Name: Reichert PT100 Portable (Tonometer) Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact T… | 2002 |
| * | K871335 | Topcon Computerized Tonometer CT-10Summary page 5…eichert PT100 Portable (Tonometer) Regulation Number: 21 CFR 886.1930 Regulation Name: Non-Contact Tonometer Regulatory Class: Class II Product Code: HKX K871335 Trade/Device Name: TOPCON COMPUTERIZED TONOMETER CT-80 Regulation Number: 21 CFR 886.1930 Regulation Name: Tonometer, AC… | 1987 |
| † | K133234 | T-Type D-Kat, R-Type D-Kat | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223739 | VS Tabletop Tonometer | 2023 | 0 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K223739 (Medimaging Integrated Solution, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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?
MiiS Horus Scope DPT 100 is a digital portable tonometer used to measure intraocular pressure of eyeball.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K181260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181260: MiiS Horus Scope DPT 100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181260
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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