FDA product code BZO: Set, Tubing And Support, Ventilator (W Harness)
BZO is the FDA product code for set, tubing and support, ventilator (w harness). It is a Class I device, regulated under 21 CFR 868.5975 and reviewed by the Anesthesiology panel. FDA has cleared 88 510(k) submissions under BZO, from 59 different applicants. The average 510(k) review took 44 days (median 35). FDA has posted 23 recalls for BZO devices, 15 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Set, Tubing And Support, Ventilator (W Harness) |
| Device class | Class I |
| Regulation | 21 CFR 868.5975 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BZO clearance
Top BZO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Prima, Inc. | 5 | 1995-05-22 |
| Airlife, Inc. | 5 | 1984-03-05 |
| Nova-Ventrx | 4 | 1989-08-10 |
| Dryden Corp. | 3 | 1987-10-20 |
| Cygnus Research Corp. | 3 | 1983-05-03 |
54 more applicants have BZO clearances. See the full list in Caduvo.
Most recent BZO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K953784 | Unicor, Inc. | UNICOR, INC. CORRUGATED TUBING | 1995-09-19 | 36 |
| K953785 | Unicor, Inc. | UNICOR, INC. VENTILATOR HOSES | 1995-09-18 | 35 |
| K952011 | Prima, Inc. | PRIMA BREATHING BAGS | 1995-05-22 | 24 |
| K952022 | Prima, Inc. | PRIMA VOLUMN VENTILATORSS | 1995-05-22 | 24 |
| K952010 | Prima, Inc. | PRIMA VENTILATOR HOSES | 1995-05-22 | 24 |
Recalls for BZO devices
23 product recalls in 14 recall events; 15 initiated in the last five years and 9 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2022 | 1 |
| 2023 | 7 |
| 2024 | 2 |
| 2025 | 3 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code BZO?
BZO is the FDA product code for set, tubing and support, ventilator (w harness). It is a Class I device, regulated under 21 CFR 868.5975 and reviewed by the Anesthesiology panel.
What device class is BZO?
Class I, regulation 21 CFR 868.5975. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BZO?
Across 88 cleared submissions the average was 44 days from receipt to decision (median 35).
Which companies have the most BZO clearances?
Prima, Inc. (5); Airlife, Inc. (5); Nova-Ventrx (4); Dryden Corp. (3); Cygnus Research Corp. (3).
Have BZO devices been recalled?
Yes: 23 product recalls across 14 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code BZO
- Run a recall and safety report across every BZO manufacturer
- Watch product code BZO 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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