# OBO: Tomography, Optical Coherence

- Device class: 2; regulation: 21 CFR 886.1570; FDA's rule: 510(k) required
- FDA decisions: 67
- 510(k) review time 2021–2025: median 157 days (middle half 143–209)
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2017: 4
- 2018: 6
- 2019: 5
- 2020: 2
- 2021: 1
- 2022: 2
- 2023: 7
- 2024: 8
- 2025: 3
- 2026: 2

## Most-cited predicates
- K111157: CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER, MACULAR, OPTIC NERVE HEAD, and GANGLION CELL NORMATIVE DATABASES (2012), cited by 6
- K071250: CA, Model: Cam (2007), cited by 5
- K112184: Cirrus Photo (2012), cited by 5
- K083291: Cirrus HD-Oct with Retinal Nerve Fiber Layer and Macular Normative Databases, Model 4000 (2009), cited by 4
- K150977: Cirrus HD-Oct (2015), cited by 4
- K180660: Avanti (2018), cited by 3
- K181534: Cirrus HD-Oct (2019), cited by 3
- K161509: 3D OCT-1 Maestro (2016), cited by 3
- K062552: RTVUE (2006), cited by 3
- K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (2017), cited by 3

Source page: https://510kreport.com/product-code/OBO
Data by year (CSV): https://510kreport.com/product-code/OBO.csv