FDA product code · Anesthesiology

Arterial Blood Sampling Kit

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

CBTClass I21 CFR 868.110058 decisions since 197718 recalls

58 FDA decisions since 1977. 18 recalls name this code, 0 of them Class I. The most-cited predicate is K071269, named by 1 later device.

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

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 CBT 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 · CBT

2in 2007

2007high 2 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBT

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

Recalls per year · CBT

14in 2011

2007high 14 (2011) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CBT

20in 2025

2007high 30 (2016) · low 5 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	2	—	2	5
2008	0	—	0	10
2009	0	—	0	7
2010	0	—	0	20
2011	0	—	14	6
2012	0	—	0	14
2013	0	—	0	13
2014	0	—	0	6
2015	0	—	0	10
2016	0	—	0	30
2017	0	—	0	22
2018	0	—	0	15
2019	0	—	0	19
2020	0	—	0	10
2021	0	—	0	24
2022	0	—	0	13
2023	0	—	0	13
2024	0	—	0	25
2025	0	—	0	20
2026	0	—	2	—

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

Planning a device in CBT? 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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What has FDA decided in CBT lately?

What has been recalled in CBT lately?

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