510(k) · Cleared
ClearedEchoscan, Model US-1800
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · IYO System, Imaging, Pulsed Echo, Ultrasonic
Cleared on May 3, 2002 as substantially equivalent to K903326 (Nidek, Inc., 1990) after a 46-day review. Its family tree reaches back 1 generation to 1990. 2 later devices descend from it.
- Decided
- May 3, 2002
- Review
- 46 days
- Class
- Class II
- Product code
- IYO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903326 (1990). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK903326 Nidek US-2000Nidek, Inc. · 1990
- This deviceK020876 Echoscan, Model US-1800Nidek, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK133132 Optical Biometer AL-ScanNidek Co., Ltd. · 2014 · Recalled
- Descendant · cites it directly · 0 of its ownK042099 Tonopach Ultrasonic Tonometer/Pachymeter Model P-201 (the Tonopach)Retinapharma Technologies, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903326 | Nidek US-2000 | Nidek, Inc. | 1990 | — |
| 0 (this device) | K020876 | Echoscan, Model US-1800 | Nidek, Inc. | 2002 | — |
| +1 | K133132 | Optical Biometer AL-Scan | Nidek Co., Ltd. | 2014 | 1 |
| +1 | K042099 | Tonopach Ultrasonic Tonometer/Pachymeter Model P-201 (the Tonopach) | Retinapharma Technologies, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2014 | 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 IYO? 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 IYO device
- #1 K243937 Accuro 3Sscore 20.5 · 18 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 |
|---|---|---|---|
| * | K903326 | Nidek US-2000Summary page 1…arable type and is substantially equivalent to the following predicate device: 510(k) No. Predicate Device Manufacturer Date Cleared ECHOSCAN Model US- Nidek Co. Ltd. K903326 11-21-90 2000 3-13-02 342 NIDEK INCORPORATED SPECIAL 510(K) MODEL US-1800 4. DEVICE DESCRIPTION The EchoScan… | 1990 |
What descends from it? (2)
2 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?
- Its one ancestor has no recall.
- Of its descendants, K133132 (Nidek Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYO devicesIYO System, Imaging, Pulsed Echo, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYO
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYO
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYO
485in 2025
MAUDE reports naming product code IYO, 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 | 20 | 17 | 4 | 39 |
| 2008 | 14 | 36 | 5 | 20 |
| 2009 | 13 | 79 | 9 | 27 |
| 2010 | 15 | 113 | 8 | 20 |
| 2011 | 11 | 69 | 0 | 58 |
| 2012 | 15 | 68 | 2 | 78 |
| 2013 | 17 | 50 | 3 | 436 |
| 2014 | 14 | 63 | 2 | 304 |
| 2015 | 19 | 46 | 1 | 268 |
| 2016 | 10 | 36 | 0 | 254 |
| 2017 | 19 | 72 | 0 | 238 |
| 2018 | 14 | 56 | 1 | 368 |
| 2019 | 13 | 59 | 1 | 537 |
| 2020 | 11 | 57 | 0 | 498 |
| 2021 | 15 | 64 | 11 | 617 |
| 2022 | 5 | 190 | 1 | 511 |
| 2023 | 11 | 177 | 0 | 527 |
| 2024 | 10 | 220 | 0 | 640 |
| 2025 | 7 | 171 | 0 | 485 |
| 2026 | 10 | 139 | 1 | — |
What is it indicated for?
The Nidek ECHOSCAN Model US-1800 is a diagnostic instrument that is intended for use in the measurement of the axial length of the eye and corneal thickness.
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/K020876 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020876: Echoscan, Model US-1800.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020876
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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