FDA product code · Ophthalmic

Digital Therapy Device For Convergence Insufficiency

Name: FDA decisions, review times, recalls and adverse event reports for product code SBN
Creator: 510(k) Report

SBNClass I21 CFR 886.1290510(k) exempt1 decision since 20240 recalls

FDA lists SBN as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 886.9 applies, such as a new intended use or a different fundamental technology. 1 FDA decision since 2024. 510(k) reviews decided 2021–2025 took a median of 267 days (half between 267 and 267). No recall names this code.

A digital therapy device for convergence insufficiency is an electronic device that incorporates binocular presentations on visual displays to treat convergence insufficiency

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

FIG. A — Illustration, ophthalmic panel

Twenty years of SBN at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · SBN

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SBN

Too few SBN 510(k)s in any year since 2007 to give a median.

Recalls per year · SBN

No recall names SBN since 2007.

Adverse event reports per year · SBN

No MAUDE report names SBN since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

FIG. 1 — SBN by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SBN? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 886.1290.

HPL Device, Fixation, Ac-Powered, Ophthalmic NXR Fixation, Vision Training, Binocular

Digital Therapy Device For Convergence Insufficiency

What has FDA decided in SBN lately?

Related product codes