FDA product code · Anesthesiology

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

BTSClass II21 CFR 868.5720510(k) required6 decisions since 19771 recall

6 FDA decisions since 1977. 1 recall names this code; it is not Class I. The most-cited predicate is K771219, named by 3 later devices.

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 BTS 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 · BTS

FDA has decided no BTS device since 2007.

Median 510(k) review, days · BTS

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

Recalls per year · BTS

No recall names BTS since 2007.

Adverse event reports per year · BTS

204in 2025

2007high 312 (2015) · low 0 (2008)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	1
2008	—	0
2009	—	2
2010	—	24
2011	—	29
2012	—	89
2013	—	116
2014	—	228
2015	—	312
2016	—	226
2017	—	190
2018	—	124
2019	—	122
2020	—	91
2021	—	110
2022	—	140
2023	—	162
2024	—	172
2025	—	204
2026	—	—

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

Planning a device in BTS? 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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Which predicates do BTS devices cite most?

What has FDA decided in BTS lately?

What has been recalled in BTS lately?