FDA product code · Anesthesiology

Tent, Oxygen, Electrically Powered

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

BYKClass II21 CFR 868.5710510(k) required3 decisions since 19810 recalls

3 FDA decisions since 1981. No recall names this code.

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, anesthesiology panel

Twenty years of BYK 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 · BYK

FDA has decided no BYK device since 2007.

Median 510(k) review, days · BYK

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

Recalls per year · BYK

No recall names BYK since 2007.

Adverse event reports per year · BYK

No MAUDE report names BYK since 2007.

View these four charts as a table

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

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

Planning a device in BYK? 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

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Tent, Oxygen, Electrically Powered

What has FDA decided in BYK lately?

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