510(k) Report

510(k) · Cleared

Cleared

Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct

K063191510(k) TraditionalCleared Oct 31, 200611-day reviewClass II21 CFR 886.1570

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heidelberg Engineering · OBO Tomography, Optical Coherence

Cleared on Oct 31, 2006 as substantially equivalent to K012727 (Carl Zeiss Ophthalmic Systems, Inc., 2002) after an 11-day review. Its family tree reaches back 1 generation to 2002. 43 later devices descend from it.

Decided
Oct 31, 2006
Review
11 days
Class
Class II
Product code
OBO
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K012727 (2002). 43 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2012: 3 descendants cleared2010: 1 descendant cleared2016: 2 descendants cleared2011: 1 descendant cleared2015: 2 descendants cleared2014: 3 descendants cleared2017: 3 descendants cleared2019: 3 descendants cleared2018: 7 descendants cleared2020: 2 descendants cleared2024: 6 descendants cleared2021: 1 descendant cleared2023: 4 descendants cleared2025: 3 descendants cleared2026: 2 descendants clearedK012727 · Humphrey OCT3 · Carl Zeiss Ophthalmic Systems, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 7 descendants4 generations forward: 10 descendants5 generations forward: 8 descendants6 generations forward: 6 descendants7 generations forward: 2 descendants8 generations forward: 1 descendant9 generations forward: 2 descendants10 generations forward: 2 descendants K012727 · Humphrey OCT3 · Carl Zeiss Ophthalmic Systems, Inc. · 20020+5+10
  1. Root · 1 generation backK012727 Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc. · 2002
  2. This deviceK063191 Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model…Heidelberg Engineering · 2006
  3. Descendant · cites it directly · 41 of its ownK101223 Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct…Heidelberg Engineering · 2010
  4. Descendant · 2 generations on · 24 of its ownK111157 CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE…Carl Zeiss Meditec, Inc. · 2012
  5. Descendant · cites it directly · 15 of its ownK121993 Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis…Heidelberg Engineering GmbH · 2012
  6. Descendant · 2 generations on · 14 of its ownK152205 Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT…Heidelberg Engineering GmbH · 2016
  7. Descendant · 3 generations on · 13 of its ownK172649 Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis…Heidelberg Engineering GmbH · 2017

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 32014: 32015: 22016: 22017: 32018: 72019: 32020: 22021: 12023: 42024: 62025: 32026: 2
2010high 7 (2018) · low 0 (2013)2026

Most influential descendants

Showing 5 of 43 · See all
  • K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010 · cites it directly41descendants
  • K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION…Carl Zeiss Meditec, Inc. · 2012 · 2 generations on24descendants
  • K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH · 2012 · cites it directly15descendants
  • K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH · 2016 · 2 generations on14descendants
  • K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis…Heidelberg Engineering GmbH · 2017 · 3 generations on13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012727Humphrey OCT3Carl Zeiss Ophthalmic Systems, Inc.2002—
0 (this device)K063191Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/OctHeidelberg Engineering2006—
+1K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra…Heidelberg Engineering2010—
+2K111157CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and…Carl Zeiss Meditec, Inc.2012—
+1K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct…Heidelberg Engineering GmbH2012—
+2K152205Spectralis HRA + OCT and variants (e.g.s below), Spectralis FA+OCT, Spectralis…Heidelberg Engineering GmbH2016—
+3K172649Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT…Heidelberg Engineering GmbH2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201230
201430
201520
201620
201730
201870
201930
202020
202110
202340
202460
202530
202620
FIG. 1 — Lineage of K063191, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250868 SPECTRALIS HRA+OCT and variantsscore 16.2 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K012727Humphrey OCT3
Summary page 1
…dd-on to the HRA 2 is substantially equivalent to the Carl Zeiss Ophtalmic Systems Inc. Humphrey Octical Coherence Tomographer 3, Humphrey OCT3, a 510 (k)cleared device (K012727). Device Description The HRA 2 / OCT is an add-on to the Heidelberg Retina Angiograph (HRA 2). It is intended for the imaging…
Carl Zeiss Ophthalmic Systems, Inc.2002—

Also cleared against K012727: 3 other devices →

What descends from it? (43)

See all 43

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering201041
K121993Spectralis Hra + Oct and Variants, Spectralis FA+ Oct, Spectralis Icga +Oct, Spectralis…Heidelberg Engineering GmbH201215

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, K101223 (Heidelberg Engineering, 2010) has gone furthest, with 41 descendants of its own.
  • 3 other devices also cite its predicate K012727.

How does its category compare?

All OBO devices

OBO Tomography, Optical Coherence: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OBO

3in 2025

2007: 22008: 22009: 42010: 22011: 22012: 32013: 22014: 32015: 12016: 42017: 42018: 62019: 52020: 22021: 12022: 22023: 72024: 82025: 32026 (partial year): 2
2007high 8 (2024) · low 1 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBO

125in 2025

2009: 151 days median2012: 269 days median2014: 152 days median2016: 125 days median2017: 118 days median2018: 87 days median2019: 249 days median2023: 262 days median2024: 157 days median2025: 125 days median
2007high 269 (2012) · low 87 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBO

1in 2022

2010: 12011: 22012: 22018: 12021: 12022: 12026 (partial year): 1
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OBO

4in 2025

2013: 22016: 12018: 12021: 12023: 32024: 32025: 4
2007high 4 (2025) · low 0 (2007)2025

MAUDE reports naming product code OBO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20082—00
2009415100
20102—10
20112—20
2012326920
20132—02
2014315200
20151—00
2016412501
2017411800
201868711
2019524900
20202—00
20211—11
20222—10
2023726203
2024815703
2025312504
20262—1—

What is it indicated for?

The OCT add-on to the HRA 2 is intended for use for the imaging of the retina and retinal structures, and for aiding in the assessment and management of various diseases of the posterior segment, such like age-related macula degeneration, diabetic retinopathy, and glaucoma.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K012727

3 other devices cite the same predicate.

  • K063343Bioptigen Spectral Domain Ophthalmic Imaging SystemBioptigen, Inc. · 2006
  • K062552RTVUEOptovue, Inc. · 2006
  • K030433Stratusoct with RNFL Normative DatabaseCarl Zeiss Meditec, Inc. · 20031 recall

More from Heidelberg Engineering

9 FDA decisions under this applicant name. See the company

  • K101223Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FAHeidelberg Engineering · 2010
  • K052935Heidelberg Engineering Slitlamp-Oct (SL-Oct)Heidelberg Engineering · 2006
  • K042742Heidelberg Retina Tomograph II / Rostock Cornea Module (HRT II / RCM)Heidelberg Engineering · 2004
  • K971671Heidelberg Retina Angiograph FA/Icga (Hra/C)Heidelberg Engineering · 1997
  • K944261Retina AngiographHeidelberg Engineering · 1994

Recent decisions in OBO

The OBO category page

  • K261019AnterionHeidelberg Engineering GmbH · 2026
  • K253837SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex ModuleHeidelberg Engineering GmbH · 2026
  • K252633Unity DX (Udx)Cylite Pty., Ltd. · 2025
  • K250553Tomey Cornea/Anterior Segment OCT (CASIA2)Tomey Corporation · 2025
  • K250868SPECTRALIS HRA+OCT and variantsHeidelberg Engineering GmbH · 2025

https://510kreport.com/device/K063191 · printed Nov 6, 2026

Cite this page

510(k) Report. “K063191: Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063191

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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