510(k) · Cleared
ClearedTopcon Model TRC-NW200 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 Nov 5, 2004 as substantially equivalent to K980246 (Canon USA, Inc., 1998) and 2 other predicates after a 165-day review. Its family tree reaches back 3 generations to 1995. 79 later devices descend from it.
- Decided
- Nov 5, 2004
- Review
- 165 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K941234 (1995). 4 ancestors in all. 79 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 2 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 1 generation backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- This deviceK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- Descendant · cites it directly · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- Descendant · 2 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- Descendant · cites it directly · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · cites it directly · 28 of its ownK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- Descendant · 3 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
Showing 5 of 79 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 79 · See all- K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · cites it directly63descendants
- K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 2 generations on41descendants
- K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · cites it directly30descendants
- K100207Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010 · cites it directly28descendants
- K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 3 generations on24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −2 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −1 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| 0 (this device) | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| +1 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| +2 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| +1 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +1 | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| +3 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NMSummary page 1…Trade Name: Canon Model Name: CR6-45NM Classification Name: 86 I{KI 5 10(k) Number: K 980246 2) Manufacturer: Canon, Inc. Trade Name: Canon Model Name:… | 1998 |
| * | K031629 | Canon Non-Mydriatic Retinal Camera, Model CR-DgiSummary page 1…Trade Name: Canon Model Name: CR-DGi Classification Name: 86 111( 510(k) Number: K 031629 3) Manufacturer: Nidek, Inc. Trade Name: Nidek Model Name:… | 2003 |
| * | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000Summary page 1…Trade Name: Nidek Model Name: NM-1000 Classification Name: 86 HKI 5 10(k) Number: K 014274 219 Description of Device: The Topcon TRC-NW200 is a non-mydriatic o… | 2002 |
What descends from it? (79)
See all 795 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 9 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K062295 (Medivision Medical Imaging, Ltd., 2006) has gone furthest, with 63 descendants of its own.
- 4 other devices also cite its predicate K980246.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Topcon Model TRC-NW200 Non-Mydriatic Camera is intended for use in capturing images of the retina and the anterior segment of the eye and presenting the data to the eyecare professional, without the use of a mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041367 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041367: Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041367
Report an extraction error
Are you the manufacturer?
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