510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
CBTClass I

Arterial Blood Sampling Kit

21 CFR 868.1100 / Anesthesiology
FDA source (opens on fda.gov)

CBT is the FDA product code for Arterial Blood Sampling Kit, a class I device type, regulated under 21 CFR 868.1100. FDA's definition for this code reads: "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...". As of , FDA records hold 58 510(k) clearances under this code, the most recent dated , and 23 recalls.

Classification record

Product code
CBT
Device name
Arterial Blood Sampling Kit
FDA 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.
Regulation
21 CFR 868.1100
Device class
Class I
Review panel
Anesthesiology
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
58
Ingested recalls
23

Clearances, product code CBT

By decision year
58 clearances under product code CBT with a decision year between 1977 and 2007, 1983 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CBT by decision year
YearClearances
19772
19783
19792
19804
19813
19824
19837
19846
19851
19872
19881
19891
19904
19912
19921
19935
19943
19954
19971
20072

Applicants with the most clearances

Product code CBT
Applicants holding the most 510(k) clearances under product code CBT
ApplicantClearances
Marquest Medical Products, Inc.8
Concord Laboratories, Inc.4
Sherwood Medical Co.4
Dhd Medical Products Div. Diemolding Corp.3
Emde Corp.3
Concord/Portex2
Devon Industries, Inc.2
Martell Medical Products, Inc.2
Abbott Medical2
Akzona, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order