510(k) · Cleared
ClearedTearView
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beyond 700 Pty, Ltd. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Jun 22, 2026 as substantially equivalent to K111771 (United Integrated Services Co., Ltd., 2011) after a 269-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 22, 2026
- Review
- 269 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913929 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991 · Recalled
- 4 generations backK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- 3 generations backK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- 2 generations backK091935 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009
- 1 generation backK111771 Non-Contact Tear Film ThermograghUnited Integrated Services Co., Ltd. · 2011
- This deviceK253176 TearViewBeyond 700 Pty, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | 5 |
| −4 | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| −3 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| −2 | K091935 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2009 | — |
| −1 | K111771 | Non-Contact Tear Film Thermogragh | United Integrated Services Co., Ltd. | 2011 | — |
| 0 (this device) | K253176 | TearView | Beyond 700 Pty, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 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 HKI? 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 HKI device
- #1 K251353 Eyer 2score 12.2 · 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 |
|---|---|---|---|
| * | K111771 | Non-Contact Tear Film ThermograghSummary page 5…lation: 21 CFR 886.1120 Predicate Device: United Integrated Non-Contact Thermograph System Model IT-85 (K111771) Product Code HKI 1. Device Description The device TearView is a thermal camera designed to be used for e… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 35 years and passes through 6 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HKI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKI
167in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKI
1in 2023
MAUDE reports naming product code HKI, 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 | 3 |
| 2008 | 5 | 29 | 0 | 1 |
| 2009 | 11 | 104 | 0 | 1 |
| 2010 | 6 | 140 | 0 | 0 |
| 2011 | 7 | 160 | 0 | 0 |
| 2012 | 5 | 179 | 1 | 2 |
| 2013 | 7 | 141 | 0 | 22 |
| 2014 | 4 | 135 | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 4 | 146 | 1 | 66 |
| 2017 | 2 | — | 1 | 20 |
| 2018 | 6 | 71 | 1 | 14 |
| 2019 | 4 | 73 | 0 | 0 |
| 2020 | 5 | 182 | 0 | 5 |
| 2021 | 4 | 155 | 0 | 3 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 5 | 259 | 0 | 1 |
| 2024 | 3 | 28 | 0 | 0 |
| 2025 | 4 | 167 | 0 | 0 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
TearView is an ophthalmic camera that is intended to be used by an eye care specialist in adult patients to take digital images of the eye and surrounding areas.
TearView is a non-contact thermograph that captures and stores images of thermal (emissivity) pattern of the ocular surface including its tear film during blinking.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253176: TearView.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253176
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026