510(k) · Cleared
ClearedTRC-NW8 Non-Mydriatic Retinal Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Corp. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on May 10, 2013 as substantially equivalent to K100207 (Topcon Corp., 2010) after a 94-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- May 10, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K941234 (1995). 10 ancestors in all, the oldest K946058 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 3 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 2 generations backK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- 1 generation backK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- This deviceK130289 TRC-NW8 Non-Mydriatic Retinal CameraTopcon Corp. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −3 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −2 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| −1 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| 0 (this device) | K130289 | TRC-NW8 Non-Mydriatic Retinal Camera | Topcon Corp. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 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 12.7 · 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? (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 |
|---|---|---|---|
| * | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8FSummary page 2…t Code: HKI K130289 Predicate Devices Topeon Medical Systems TRC-NW8F (K100207) Purpose of the Special 510(k) notice. The TRC-NW8 is a modification to TRC-NWSF. Intended Use The TRC-NWS is intended for use… | 2010 |
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 18 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 10 ancestors has a recall.
- 3 other devices also cite its predicate K100207.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 TRC-NWS is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eye care professional, with the use of a mnydriatic or without the use of a mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130289: TRC-NW8 Non-Mydriatic Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130289
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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