FDA product code · Ear, nose and throat

Laryngeal Injection Set With Led Light

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

SBSClass I21 CFR 874.4420510(k) exempt1 decision since 20240 recalls

FDA lists SBS as exempt from 510(k): a device of this type needs no clearance unless one of the limits in 21 CFR 874.9 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 352 days (half between 352 and 352). No recall names this code.

A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook…

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, ear, nose and throat panel

Twenty years of SBS 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 · SBS

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SBS

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

Recalls per year · SBS

No recall names SBS since 2007.

Adverse event reports per year · SBS

No MAUDE report names SBS 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 — SBS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in SBS? 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 874.4420.

KBG Trocar, Sinus KBL Depressor, Metal Tongue, Surgical KAS Knife, Nasal KBB Rongeur, Nasal KCH Hook, Tracheal KBQ Knife, Tonsil JZF Tube, Ear Suction KAQ Gouge, Nasal, Ent KAP Curette, Nasal KAB Trocar, Laryngeal KBH Adenotome KAW Punch, Antrum

Laryngeal Injection Set With Led Light

What has FDA decided in SBS lately?

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