FDA product code CAZ: Anesthesia Conduction Kit
CAZ is the FDA product code for anesthesia conduction kit. It is a Class II device, regulated under 21 CFR 868.5140 and reviewed by the Anesthesiology panel. FDA has cleared 155 510(k) submissions under CAZ, 2 in the last five years, from 72 different applicants. The average 510(k) review took 129 days (median 108). FDA has posted 220 recalls for CAZ devices, 14 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 | Anesthesia Conduction Kit |
| Device class | Class II |
| Regulation | 21 CFR 868.5140 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CAZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 91 |
| 2020 | 1 | 104 |
| 2021 | 1 | 267 |
| 2022 | 1 | 413 |
| 2023 | 1 | 194 |
Compare with all 510(k) review times · Search every CAZ clearance
Top CAZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Arrow Intl., Inc. | 11 | 2002-06-19 |
| Kendall Healthcare Products Co. Div.Of Tyco Health | 9 | 1996-05-30 |
| PAJUNK GmbH Medizintechnologie | 8 | 2020-12-29 |
| B.Braun Medical, Inc. | 7 | 2012-01-24 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 7 | 1996-05-20 |
67 more applicants have CAZ clearances. See the full list in Caduvo.
Most recent CAZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K222341 | Arrow International, LLC | Arrow 0.2 Micron Flat Filter, GVS | 2023-02-13 | 194 |
| K210983 | Becton, Dickinson and Company | BD Epilor Syringe | 2022-05-19 | 413 |
| K201356 | Jiangsu Caina Medical Co.,Ltd | Plastic LOR Syringe | 2021-02-12 | 267 |
| K202699 | PAJUNK GmbH Medizintechnologie | E-Cath STIM acc. Tsui | 2020-12-29 | 104 |
| K190345 | PAJUNK GmbH Medizintechnologie | VPC | 2019-05-16 | 91 |
Recalls for CAZ devices
220 product recalls in 39 recall events; 14 initiated in the last five years and 14 still open. Most recent: 2026-04-27.
| Year | Recalls |
|---|---|
| 2018 | 6 |
| 2019 | 11 |
| 2020 | 39 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 12 |
Frequently asked questions
What is FDA product code CAZ?
CAZ is the FDA product code for anesthesia conduction kit. It is a Class II device, regulated under 21 CFR 868.5140 and reviewed by the Anesthesiology panel.
What device class is CAZ?
Class II, regulation 21 CFR 868.5140. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAZ?
Across 155 cleared submissions the average was 129 days from receipt to decision (median 108).
Which companies have the most CAZ clearances?
Arrow Intl., Inc. (11); Kendall Healthcare Products Co. Div.Of Tyco Health (9); PAJUNK GmbH Medizintechnologie (8); B.Braun Medical, Inc. (7); Bd Becton Dickinson Vacutainer Systems Preanalytic (7).
Have CAZ devices been recalled?
Yes: 220 product recalls across 39 recall events; the most recent began 2026-04-27.
Next steps
- Run an FDA pathway report with predicate devices for product code CAZ
- Run a recall and safety report across every CAZ manufacturer
- Watch product code CAZ 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.
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