510(k) · Cleared
ClearedLipiview Ocular Surface Interferometer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tearscience, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Oct 23, 2009 as substantially equivalent to K980295 (Mrp Group, Inc., 1998) and 1 other predicate after a 115-day review. Its family tree reaches back 3 generations to 1991. 6 later devices descend from it.
- Decided
- Oct 23, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913929 (1991). 5 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK913929 DFC-1024 & DFC-512 Digital Imaging SystemOphthalmic Imaging Systems · 1991 · Recalled
- 2 generations backK971685 Imagescape Digital Retinal Image SystemTomey Corporation USA · 1997
- 1 generation backK980295 Ophthavision Imaging SystemMrp Group, Inc. · 1998
- This deviceK091935 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK122481 Lipiview Ocular Surface InterferometerTearscience, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK152869 LipiView II Ocular Surface InterferometerTearscience, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK111771 Non-Contact Tear Film ThermograghUnited Integrated Services Co., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK253176 TearViewBeyond 700 Pty, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK190573 KOWA DR-1aKowa Company, Ltd. · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K122481Lipiview Ocular Surface InterferometerTearscience, Inc. · 2012 · cites it directly2descendants
- K152869LipiView II Ocular Surface InterferometerTearscience, Inc. · 2016 · cites it directly1descendant
- K111771Non-Contact Tear Film ThermograghUnited Integrated Services Co., Ltd. · 2011 · cites it directly1descendant
- K253176TearViewBeyond 700 Pty, Ltd. · 2026 · 2 generations on0descendants
- K190573KOWA DR-1aKowa Company, Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913929 | DFC-1024 & DFC-512 Digital Imaging System | Ophthalmic Imaging Systems | 1991 | 5 |
| −2 | K971685 | Imagescape Digital Retinal Image System | Tomey Corporation USA | 1997 | — |
| −1 | K980295 | Ophthavision Imaging System | Mrp Group, Inc. | 1998 | — |
| 0 (this device) | K091935 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2009 | — |
| +1 | K122481 | Lipiview Ocular Surface Interferometer | Tearscience, Inc. | 2012 | — |
| +1 | K152869 | LipiView II Ocular Surface Interferometer | Tearscience, Inc. | 2016 | — |
| +1 | K111771 | Non-Contact Tear Film Thermogragh | United Integrated Services Co., Ltd. | 2011 | — |
| +2 | K253176 | TearView | Beyond 700 Pty, Ltd. | 2026 | — |
| +1 | K190573 | KOWA DR-1a | Kowa Company, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 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 K253176 TearViewscore 12.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K980295 | Ophthavision Imaging SystemSummary page 1…Class 11 PRODUCT CODES: HKI and HJO PREDICATE DEVICES: 1. OphthaVision Imaging System, MRP Group, Inc. (K980295; cleared May 19, 1998; Product Code HKI; 21 CFR 886.1120; Class LI)… | 1998 |
| * | K973064 | Keeler Tearscope-PlusSummary page 1…Product Code HKI; 21 CFR 886.1120; Class LI) 2. Tearscope-Plus, Keeler Instruments, Inc. (K973064; cleared April 7, 1998; Product Code HJO; 21 CFR 886.1850; Class II) DEVICE DESCRIPTION: The… | 1998 |
What descends from it? (6)
4 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 18 years and passes through 4 companies; a new generation was cleared every 5.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K122481 (Tearscience, Inc., 2012) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K980295.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The LipiView ® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091935: Lipiview Ocular Surface Interferometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091935
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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