FDA product code BZA: Connector, Airway (Extension)
BZA is the FDA product code for connector, airway (extension). It is a Class I device, regulated under 21 CFR 868.5810 and reviewed by the Anesthesiology panel. FDA has cleared 94 510(k) submissions under BZA, from 59 different applicants. The average 510(k) review took 53 days (median 37). FDA has posted 38 recalls for BZA devices, 9 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Connector, Airway (Extension) |
| Device class | Class I |
| Regulation | 21 CFR 868.5810 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BZA clearance
Top BZA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Airlife, Inc. | 11 | 1981-08-12 |
| Dhd Medical Products Div. Diemolding Corp. | 8 | 1986-03-20 |
| Intersurgical, Inc. | 4 | 1992-06-17 |
| Prima, Inc. | 3 | 1994-12-02 |
| Dhd Diemolding Healthcare Div. | 3 | 1992-12-04 |
54 more applicants have BZA clearances. See the full list in Caduvo.
Most recent BZA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K083702 | Mergenet Medical | TRACH-ASSIST | 2009-03-05 | 80 |
| K954383 | Polamedco, Inc. | SURELOC CIRCUIT CONNECTOR | 1995-12-22 | 94 |
| K954197 | Engstrom Medical | DISPOSABLE FLEX TUBE | 1995-10-26 | 50 |
| K953786 | Unicor, Inc. | UNICOR, INC. CONNECTORS & AIRWAY EXTENSIONS | 1995-09-19 | 36 |
| K952824 | Intertex Medical, Inc. | NEO-LINK, DISPOSABLE NEONATAL AIR WAY CONNECTOR | 1995-07-20 | 30 |
Recalls for BZA devices
38 product recalls in 11 recall events; 9 initiated in the last five years and 9 still open. Most recent: 2025-11-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 5 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code BZA?
BZA is the FDA product code for connector, airway (extension). It is a Class I device, regulated under 21 CFR 868.5810 and reviewed by the Anesthesiology panel.
What device class is BZA?
Class I, regulation 21 CFR 868.5810. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZA?
Across 94 cleared submissions the average was 53 days from receipt to decision (median 37).
Which companies have the most BZA clearances?
Airlife, Inc. (11); Dhd Medical Products Div. Diemolding Corp. (8); Intersurgical, Inc. (4); Prima, Inc. (3); Dhd Diemolding Healthcare Div. (3).
Have BZA devices been recalled?
Yes: 38 product recalls across 11 recall events; the most recent began 2025-11-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BZA
- Run a recall and safety report across every BZA manufacturer
- Watch product code BZA 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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