510(k) · Cleared
ClearedSpectralis Anterior Segment Module (Spectralis Asm)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heidelberg Engineering GmbH · OBO Tomography, Optical Coherence
Cleared on Nov 8, 2011 as substantially equivalent to K071250 (Optovue, Inc., 2007) and 1 other predicate after a 15-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Nov 8, 2011
- Review
- 15 days
- Class
- Class II
- Product code
- OBO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K941234 (1995). 19 ancestors in all, the oldest K946058 (1995). No later device cites it as a predicate yet.
- Root · 6 generations backK941234 Non-Mydriatic Retinal CameraCanon USA, Inc. · 1995
- 5 generations backK980246 Non-Mydriatic Retinal Camera, Model CR6-45NMCanon USA, Inc. · 1998
- 4 generations backK014274 Non-Mydriatic Fundus Camera, Model NM-1000Nidek, Inc. · 2002
- 3 generations backK041367 Topcon Model TRC-NW200 Non-Mydriatic Retinal CameraTopcon Corp. · 2004
- 2 generations backK062295 Iri Integrated Retinal ImagerMedivision Medical Imaging, Ltd. · 2006
- 1 generation backK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
- This deviceK113129 Spectralis Anterior Segment Module (Spectralis Asm)Heidelberg Engineering GmbH · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K941234 | Non-Mydriatic Retinal Camera | Canon USA, Inc. | 1995 | — |
| −5 | K980246 | Non-Mydriatic Retinal Camera, Model CR6-45NM | Canon USA, Inc. | 1998 | — |
| −4 | K014274 | Non-Mydriatic Fundus Camera, Model NM-1000 | Nidek, Inc. | 2002 | — |
| −3 | K041367 | Topcon Model TRC-NW200 Non-Mydriatic Retinal Camera | Topcon Corp. | 2004 | — |
| −2 | K062295 | Iri Integrated Retinal Imager | Medivision Medical Imaging, Ltd. | 2006 | — |
| −1 | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra… | Heidelberg Engineering | 2010 | — |
| 0 (this device) | K113129 | Spectralis Anterior Segment Module (Spectralis Asm) | Heidelberg Engineering GmbH | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 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? (2)
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 |
|---|---|---|---|
| * | K071250 | CA, Model: CamSummary page 1…tion: Class II Substantial Equivalence The Heidelberg Spectralis with Anterior Segment Module is substantially equivalent to the Optovue RTVue 100/CA (K(071250), which is technologically similar devices for anterior segment imaging. A second predicate device is chosen, the Heidelberg Spec… | 2007 |
| * | K101223 | Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FASummary page 1…e RTVue 100/CA (K(071250), which is technologically similar devices for anterior segment imaging. A second predicate device is chosen, the Heidelberg Spectralis HRA+OCT (K101223) because it is the "parent" device to the Spectralis ASM. Device Description The Spectralis Anterior Segment Module (Spectralis… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 2 of the 19 ancestors have a recall of any class.
- 4 other devices also cite its predicate K071250.
How does its category compare?
All OBO devicesOBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Spectralis Anterior Segment Module is an accessory to the Spectralis HRA+OCT, and is indicated for imaging the anterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113129: Spectralis Anterior Segment Module (Spectralis Asm).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113129
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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