510(k) · Cleared
ClearedHP-Oct (HP-Oct)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cylite Pty., Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Mar 8, 2024 as substantially equivalent to K181534 (Carl Zeiss Meditec, Inc., 2019) after a 266-day review. Its family tree reaches back 10 generations to 2002. 1 later device descends from it.
- Decided
- Mar 8, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K012727 (2002). 26 ancestors in all, the oldest K946058 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 6 generations between
- 3 generations backK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- 2 generations backK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · Recalled
- 1 generation backK181534 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · Recalled
- This deviceK231760 HP-Oct (HP-Oct)Cylite Pty., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
Show all 10 generations
- Root · 10 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 9 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 8 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 7 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 6 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 5 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 4 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 3 generations backK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- 2 generations backK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016 · Recalled
- 1 generation backK181534 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · Recalled
- This deviceK231760 HP-Oct (HP-Oct)Cylite Pty., Ltd. · 2024
Most influential descendants
Showing 1 of 1 · See all- K252633Unity DX (Udx)Cylite Pty., Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −9 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −8 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −7 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −6 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −5 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −4 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| −3 | K150977 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2015 | — |
| −2 | K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016 | 1 |
| −1 | K181534 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2019 | 2 |
| 0 (this device) | K231760 | HP-Oct (HP-Oct) | Cylite Pty., Ltd. | 2024 | — |
| +1 | K252633 | Unity DX (Udx) | Cylite Pty., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 HJO? 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 HJO device
- #1 K253834 Visuref 600score 13.1 · 8 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 |
|---|---|---|---|
| * | K181534 | Cirrus HD-OctSummary page 4…oduct Code: OBO 2. Predicate Device Company: Carl Zeiss Meditec, Inc. Device: Cirrus HD-OCT 5000 (K181534) The subject device and predicate device are both intended for non-contact imaging and analysis of ocular structures. Both devic… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252633 | Unity DX (Udx) | 2025 | 0 |
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 22 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K252633 (Cylite Pty., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K181534.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | 1 | — | 0 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The HP-OCT™ instrument is a non-contact ophthalmic imaging and analysis device. It is indicated for visualization of the posterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231760 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231760: HP-Oct (HP-Oct).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231760
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