510(k) · Cleared
Recalled · Class II · 2018PLEX Elite 9000 SS-OCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · OBO Tomography, Optical Coherence
Cleared on Oct 26, 2016 as substantially equivalent to K150977 (Carl Zeiss Meditec, Inc., 2015) after a 182-day review. Its family tree reaches back 8 generations to 2002. 7 later devices descend from it. It has been recalled once.
- Decided
- Oct 26, 2016
- Review
- 182 days
- Class
- Class II
- Product code
- OBO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K012727 (2002). 24 ancestors in all, the oldest K946058 (1995). 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
- 7 generations backK030433 Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 2003 · Recalled
- 6 generations backK033123 Stratusoct with RNFL & Macula Normative DatabaseCarl Zeiss Meditec, Inc. · 2004 · Recalled
- 5 generations backK063343 Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
- 4 generations backK071250 CA, Model: CamOptovue, Inc. · 2007
- 3 generations backK101505 Rtvue Model Rtvue 100Optovue, Inc. · 2010 · Recalled
- 2 generations backK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
- 1 generation backK150977 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2015
- This deviceK161194 PLEX Elite 9000 SS-OCTCarl Zeiss Meditec, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK181534 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK241081 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6…Topcon Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK231760 HP-Oct (HP-Oct)Cylite Pty., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK222200 Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK253893 Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K181534Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2019 · cites it directly6descendants
- K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…Topcon Corporation · 2024 · 2 generations on1descendant
- K231760HP-Oct (HP-Oct)Cylite Pty., Ltd. · 2024 · 2 generations on1descendant
- K222200Cirrus HD-OctCarl Zeiss Meditec, Inc. · 2023 · 2 generations on1descendant
- K253893Harmony Referral System with Harmony OCT Viewer (Octave)Topcon Healthcare Solutions EMEA Oy · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K012727 | Humphrey OCT3 | Carl Zeiss Ophthalmic Systems, Inc. | 2002 | — |
| −7 | K030433 | Stratusoct with RNFL Normative Database | Carl Zeiss Meditec, Inc. | 2003 | 1 |
| −6 | K033123 | Stratusoct with RNFL & Macula Normative Database | Carl Zeiss Meditec, Inc. | 2004 | 1 |
| −5 | K063343 | Bioptigen Spectral Domain Ophthalmic Imaging System | Bioptigen, Inc. | 2006 | — |
| −4 | K071250 | CA, Model: Cam | Optovue, Inc. | 2007 | — |
| −3 | K101505 | Rtvue Model Rtvue 100 | Optovue, Inc. | 2010 | 1 |
| −2 | K111157 | CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and… | Carl Zeiss Meditec, Inc. | 2012 | — |
| −1 | K150977 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2015 | — |
| 0 (this device) | K161194 | PLEX Elite 9000 SS-OCT | Carl Zeiss Meditec, Inc. | 2016 | — |
| +1 | K181534 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2019 | 2 |
| +2 | K241081 | 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6… | Topcon Corporation | 2024 | — |
| +2 | K231760 | HP-Oct (HP-Oct) | Cylite Pty., Ltd. | 2024 | — |
| +2 | K222200 | Cirrus HD-Oct | Carl Zeiss Meditec, Inc. | 2023 | — |
| +3 | K253893 | Harmony Referral System with Harmony OCT Viewer (Octave) | Topcon Healthcare Solutions EMEA Oy | 2026 | — |
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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 OBO? 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 OBO device
- #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 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 |
|---|---|---|---|
| * | K150977 | Cirrus HD-OctSummary page 4…mography System Substantial Equivalence Claimed To (21 CFR §807.92(a)(3)) Company: Carl Zeiss Meditec, Inc. Device: CIRRUS™ HD-OCT (K150977) Reference Predicate: Company: Carl Zeiss Meditec AG Device: IOLMaster 700 (K143275)… | 2015 |
| † | K143275 | IOLMaster700 | 2015 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181534 | Cirrus HD-Oct | 2019 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 16, 2018 | Class II | Z-0770-2020 | Device Design | Under certain fault conditions, the existing design may expose the operator to a hazardous voltage when contacting the metal enclosure (including mounting screws) around the up/down switch. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 24 ancestors have a recall of any class.
- Of its descendants, K181534 (Carl Zeiss Meditec, Inc., 2019) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K150977.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OBO
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBO
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBO
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBO
4in 2025
MAUDE reports naming product code OBO, 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 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 4 | 151 | 0 | 0 |
| 2010 | 2 | — | 1 | 0 |
| 2011 | 2 | — | 2 | 0 |
| 2012 | 3 | 269 | 2 | 0 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 3 | 152 | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 4 | 125 | 0 | 1 |
| 2017 | 4 | 118 | 0 | 0 |
| 2018 | 6 | 87 | 1 | 1 |
| 2019 | 5 | 249 | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 1 | 1 |
| 2022 | 2 | — | 1 | 0 |
| 2023 | 7 | 262 | 0 | 3 |
| 2024 | 8 | 157 | 0 | 3 |
| 2025 | 3 | 125 | 0 | 4 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The PLEX™ Elite 9000 Swept-Source OCT [SS-OCT] is a non-contact, high resolution, wide field of view tomographic and biomicroscopic imaging device intended for in-vivo viewing, axial cross-sectional and three-dimensional imaging of posterior ocular structures. The device is indicated for visualizing posterior ocular structures including, but not limited to, retina, retinal nerve fiber layer, ganglion cell plus inner plexiform layer, macula, optic nerve head, vitreous and choroid.
The PLEX™ Elite SS-OCT angiography is indicated as an aid in the visualization of vascular structures of the retina and choroid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161194 · printed Nov 5, 2026
Cite this page
510(k) Report. “K161194: PLEX Elite 9000 SS-OCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K161194
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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