FDA product code CBT: Arterial Blood Sampling Kit
CBT is the FDA product code for arterial blood sampling kit. It is a Class I device, regulated under 21 CFR 868.1100 and reviewed by the Anesthesiology panel. FDA has cleared 58 510(k) submissions under CBT, from 37 different applicants. The average 510(k) review took 83 days (median 58). FDA has posted 22 recalls for CBT devices, 4 initiated in the last five years.
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.
Classification
| Field | Value |
|---|---|
| Device name | Arterial Blood Sampling Kit |
| Device class | Class I |
| Regulation | 21 CFR 868.1100 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top CBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Marquest Medical Products, Inc. | 8 | 1990-09-04 |
| Sherwood Medical Co. | 4 | 1995-03-16 |
| Concord Laboratories, Inc. | 4 | 1984-05-23 |
| Dhd Medical Products Div. Diemolding Corp. | 3 | 1983-09-26 |
| Emde Corp. | 3 | 1981-05-21 |
32 more applicants have CBT clearances. See the full list in Caduvo.
Most recent CBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K071269 | Smiths Medical Asd, Inc. | HEMODRAW ARTERIAL BLOOD SAMPLING SYSTEM | 2007-08-01 | 86 |
| K070340 | Smiths Medical Asd, Inc. | SECURE ARTERIAL BLOOD SAMPLING SYSTEM | 2007-03-15 | 37 |
| K955663 | Utah Medical Products, Inc. | ABC IN-LINE BLOOD SAMPLING KIT | 1997-03-17 | 460 |
| K954015 | Devon Industries, Inc. | ABG POINT LOK NEEDLE PROTECTION DEVICE | 1995-11-20 | 87 |
| K954035 | R-Group Intl. | ACTI-FLEX ARTERIAL EXTENSION SET | 1995-09-25 | 28 |
Recalls for CBT devices
22 product recalls in 8 recall events; 4 initiated in the last five years and 3 still open. Most recent: 2026-03-16.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CBT?
CBT is the FDA product code for arterial blood sampling kit. It is a Class I device, regulated under 21 CFR 868.1100 and reviewed by the Anesthesiology panel.
What device class is CBT?
Class I, regulation 21 CFR 868.1100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CBT?
Across 58 cleared submissions the average was 83 days from receipt to decision (median 58).
Which companies have the most CBT clearances?
Marquest Medical Products, Inc. (8); Sherwood Medical Co. (4); Concord Laboratories, Inc. (4); Dhd Medical Products Div. Diemolding Corp. (3); Emde Corp. (3).
Have CBT devices been recalled?
Yes: 22 product recalls across 8 recall events; the most recent began 2026-03-16.
Next steps
- Run an FDA pathway report with predicate devices for product code CBT
- Run a recall and safety report across every CBT manufacturer
- Watch product code CBT for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.