DeviceClearance

Product code CBT— Anesthesiology

ARTERIAL BLOOD SAMPLING KIT

Classification name
Arterial Blood Sampling Kit
Device class
Class 1
Regulation
21 CFR 868.1100
Advisory panel
Anesthesiology
Total cleared
58
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code CBT under 21 CFR 868.1100, via openFDA

Market context for product code CBT

FDA has cleared 58 devices under product code CBT between 1977 and 2007, filed by 37 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code CBT

Recent clearances under product code CBT

Data sourced from openFDA. This site is unofficial and independent of the FDA.