510(k) · Cleared
ClearedNon-Mydriatic Retinal Camera, Model TRC-NW8F
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 Feb 12, 2010 as substantially equivalent to K090115 (Topcon Corp., 2009) and 2 other predicates after an 18-day review. Its family tree reaches back 5 generations to 1995. 28 later devices descend from it.
- Decided
- Feb 12, 2010
- Review
- 18 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K941234 (1995). 9 ancestors in all, the oldest K946058 (1995). 28 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 4 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 3 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 2 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 1 generation backK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- This deviceK100207 Non-Mydriatic Retinal Camera, Model TRC-NW8FTopcon Corp. · 2010
- Descendant · cites it directly · 13 of its ownK112184 Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012
- Descendant · cites it directly · 11 of its ownK123460 TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013
- Descendant · 2 generations on · 8 of its ownK161509 3D OCT-1 MaestroTopcon Corporation · 2016
- Descendant · 3 generations on · 5 of its ownK170164 3D OCT-1 MaestroTopcon Corporation · 2017
- Descendant · 2 generations on · 5 of its ownK141844 Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K112184Cirrus PhotoCarl Zeiss Meditec, Inc. · 2012 · cites it directly13descendants
- K123460TRC-NW300 Non-Mydriatic Retinal CameraTopcon Medical Systems, Inc. · 2013 · cites it directly11descendants
- K1615093D OCT-1 MaestroTopcon Corporation · 2016 · 2 generations on8descendants
- K1701643D OCT-1 MaestroTopcon Corporation · 2017 · 3 generations on5descendants
- K141844Rescan 700, Callisto EyeCarl Zeiss Meditec, AG · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −4 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −3 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −2 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −1 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| 0 (this device) | K100207 | Non-Mydriatic Retinal Camera, Model TRC-NW8F | Topcon Corp. | 2010 | — |
| +1 | K112184 | Cirrus Photo | Carl Zeiss Meditec, Inc. | 2012 | — |
| +1 | K123460 | TRC-NW300 Non-Mydriatic Retinal Camera | Topcon Medical Systems, Inc. | 2013 | — |
| +2 | K161509 | 3D OCT-1 Maestro | Topcon Corporation | 2016 | — |
| +3 | K170164 | 3D OCT-1 Maestro | Topcon Corporation | 2017 | — |
| +2 | K141844 | Rescan 700, Callisto Eye | Carl Zeiss Meditec, AG | 2014 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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? (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 |
|---|---|---|---|
| * | K090115 | Retina Camera TRC-NW7SF Mark IISummary page 2…Product Code: HKI Identification of a Legally Marketed Predicate Device The TRC-NWSF is substantially equivalent to the TRC-NW7SF MARKII (K0901 15), KOWA VX-1O (K0432l3) and TRC-NW200 (K041367). All of those predicate have same FDA Product Code HKI. General Desc… | 2009 |
| * | K043213 | Kowa VX-10Summary page 3…Basis of Substantial Equivalence The TOPCON NON-MYDRIATIC RETINAL CAMERA TRC-NW8F is as safe and effective as TOPCON TRC-NW7SF MARKII (K0901 15), KOWA VX-10 (K043213) and TOPCON TRC-NW200 (K04 1367). The NON-MYDRJATIC RETINAL CAMERA TRC-NW8F and the predicated devices have the same… | 2005 |
| * | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraSummary page 2…ation of a Legally Marketed Predicate Device The TRC-NWSF is substantially equivalent to the TRC-NW7SF MARKII (K0901 15), KOWA VX-1O (K0432l3) and TRC-NW200 (K041367). All of those predicate have same FDA Product Code HKI. General Description This product is a retinal camera design… | 2004 |
What descends from it? (28)
See all 284 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 15 years and passes through 3 companies; a new generation was cleared every 2.9 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K112184 (Carl Zeiss Meditec, Inc., 2012) has gone furthest, with 13 descendants of its own.
- 1 other device also cites its predicate K090115.
How does its category compare?
All HKI devicesHKI Camera, Ophthalmic, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 NON-MYDRIATIC RETINAL CAMERA TRC-NW8F 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 mydriatic or without Use of a mydriatic.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100207: Non-Mydriatic Retinal Camera, Model TRC-NW8F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100207
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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