510(k) · Cleared
ClearedTRC-NW300 Non-Mydriatic Retinal Camera
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Systems, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Feb 6, 2013 as substantially equivalent to K041367 (Topcon Corp., 2004) and 1 other predicate after an 89-day review. Its family tree reaches back 6 generations to 1995. 11 later devices descend from it.
- Decided
- Feb 6, 2013
- Review
- 89 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941234 (1995). 10 ancestors in all, the oldest K946058 (1995). 11 later devices descend from it, 2 citing it directly.
- 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 deviceK123460 TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013
- Descendant · cites it directly · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · 2 generations on · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · 3 generations on · 3 of its ownK231222 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023
- Descendant · 2 generations on · 3 of its ownK171370 IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · Recalled
- Descendant · 4 generations on · 2 of its ownK233561 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · cites it directly8descendants
- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · 2 generations on5descendants
- K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)Topcon Corporation · 2023 · 3 generations on3descendants
- K171370IMAGEnet 6 Ophthalmic Data SystemTopcon Corporation · 2017 · 2 generations on3descendants
- K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))Topcon Corporation · 2024 · 4 generations on2descendants
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) | K123460 | TRC-NW300 Non-Mydriatic Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
| +1 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +2 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +3 | K231222 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) | Topcon Corporation | 2023 | — |
| +2 | K171370 | IMAGEnet 6 Ophthalmic Data System | Topcon Corporation | 2017 | 1 |
| +4 | K233561 | 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) | Topcon Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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 12.7 · 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? (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 |
|---|---|---|---|
| * | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraSummary page 2…tinal Camera Classification Name Camera, Ophthalmic, AC-Powered 21 C.F.R. 886.1120 Product Code: HKI Predicate Devices Topcon Medical Systems TRC-NW200 (K04 1367) Topcon Medical Systems TRC-NWSF (K100207) Intended Use The TRC-NW300 intended for use in capturing images of the retina and th… | 2004 |
| * | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8FSummary page 2…phthalmic, AC-Powered 21 C.F.R. 886.1120 Product Code: HKI Predicate Devices Topcon Medical Systems TRC-NW200 (K04 1367) Topcon Medical Systems TRC-NWSF (K100207) Intended Use The TRC-NW300 intended for use in capturing images of the retina and the anterior segment of the eye and presenti… | 2010 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K161509 (Topcon Corporation, 2016) has gone furthest, with 8 descendants of its own.
- 4 other devices also cite its predicate K041367.
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-NW3OO 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, without the use of a maydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123460: TRC-NW300 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/K123460
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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