510(k) · Cleared
ClearedNon-Mydriatic Fundus Camera, Model NM-1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · HKI Camera, Ophthalmic, Ac-Powered
Cleared on Apr 17, 2002 as substantially equivalent to K980246 (Canon USA, Inc., 1998) after a 111-day review. Its family tree reaches back 2 generations to 1995. 96 later devices descend from it.
- Decided
- Apr 17, 2002
- Review
- 111 days
- Class
- Class II
- Product code
- HKI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941234 (1995). 96 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 1 generation backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- This deviceK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- Descendant · cites it directly · 79 of its ownK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- Descendant · 2 generations on · 63 of its ownK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- Descendant · 3 generations on · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- Descendant · 2 generations on · 30 of its ownK090115 Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009
- Descendant · cites it directly · 30 of its ownK023719 MP-1 Micro PerimeterNidek Technologies Srl · 2002
Showing 5 of 96 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 96 · See all- K041367Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004 · cites it directly79descendants
- K062295Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006 · 2 generations on63descendants
- K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · 3 generations on41descendants
- K090115Retina Camera TRC-NW7SF Mark IITopcon Corp. · 2009 · 2 generations on30descendants
- K023719MP-1 Micro PerimeterNidek Technologies Srl · 2002 · cites it directly30descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −1 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| 0 (this device) | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| +1 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| +2 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| +3 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| +2 | K090115 | Retina Camera TRC-NW7SF Mark II | Topcon Corp. | 2009 | — |
| +1 | K023719 | MP-1 Micro Perimeter | Nidek Technologies Srl | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 8 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 10 | 0 |
| 2019 | 7 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 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 12.7 · 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 |
|---|---|---|---|
| * | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NMSummary page 2…ally equivalent to the following predicate device: Predicate Device Manufacturer 510(k) No. Date Cleared Mydriatic Retinal Camera Canon CR6-45NM Non- Canon USA, Inc. K980246 May 6, 1998 12/21/01 249 NIDEK INCORPORATED ORIGINAL PREMARKET 510(k) NOTIFICATION NM-1000 FUNDUS CAMERA 4. DE… | 1998 |
What descends from it? (96)
See all 965 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 7 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K041367 (Topcon Corp., 2004) has gone furthest, with 79 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 Nidek Non-Mydriatic Fundus Camera Model NM-1000 is an ophthalmic camera that is indicated for use in capturing images of the retina and the anterior segment of the eye.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014274 · printed Nov 6, 2026
Cite this page
510(k) Report. “K014274: Non-Mydriatic Fundus Camera, Model NM-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014274
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026