FDA product code BZN: Cart, Emergency, Cardiopulmonary (Excluding Equipment)
BZN is the FDA product code for cart, emergency, cardiopulmonary (excluding equipment). It is a Class I device, regulated under 21 CFR 868.6175 and reviewed by the Anesthesiology panel. FDA has cleared 8 510(k) submissions under BZN, from 8 different applicants. The average 510(k) review took 86 days (median 96). FDA has posted 2 recalls for BZN devices.
Classification
| Field | Value |
|---|---|
| Device name | Cart, Emergency, Cardiopulmonary (Excluding Equipment) |
| Device class | Class I |
| Regulation | 21 CFR 868.6175 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every BZN clearance
Top BZN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Instrumed, Inc. | 1 | 1992-11-25 |
| Nico Metal Products Corp. | 1 | 1987-07-24 |
| Medicor USA , Ltd. | 1 | 1985-09-19 |
| Siemens Elema AB | 1 | 1984-02-04 |
| Rmp Co. | 1 | 1983-12-27 |
3 more applicants have BZN clearances. See the full list in Caduvo.
Most recent BZN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K924373 | Instrumed, Inc. | ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMP | 1992-11-25 | 89 |
| K872558 | Nico Metal Products Corp. | CART, EMERGENCY, CARDIOPULMONARY | 1987-07-24 | 25 |
| K850761 | Medicor USA , Ltd. | MODEL PCX/EMY 525A MICROPROCESSSOR CONTROL X-RAY C | 1985-09-19 | 206 |
| K840264 | Siemens Elema AB | SERVO CART 170 | 1984-02-04 | 12 |
| K832697 | Rmp Co. | RMP INTUBATION EQUIP. STORAGE TRAY | 1983-12-27 | 139 |
Recalls for BZN devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-04-23.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code BZN?
BZN is the FDA product code for cart, emergency, cardiopulmonary (excluding equipment). It is a Class I device, regulated under 21 CFR 868.6175 and reviewed by the Anesthesiology panel.
What device class is BZN?
Class I, regulation 21 CFR 868.6175. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZN?
Across 8 cleared submissions the average was 86 days from receipt to decision (median 96).
Which companies have the most BZN clearances?
Instrumed, Inc. (1); Nico Metal Products Corp. (1); Medicor USA , Ltd. (1); Siemens Elema AB (1); Rmp Co. (1).
Have BZN devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-04-23.
Next steps
- Run an FDA pathway report with predicate devices for product code BZN
- Run a recall and safety report across every BZN manufacturer
- Watch product code BZN 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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