FDA product code BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZE is the FDA product code for heater, breathing system w/wo controller (not humidifier or nebulizer. It is a Class II device, regulated under 21 CFR 868.5270 and reviewed by the Anesthesiology panel. FDA has cleared 46 510(k) submissions under BZE, 6 in the last five years, from 38 different applicants. The average 510(k) review took 193 days (median 174); 226 days on average over the last three years. FDA has posted 7 recalls for BZE devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer |
| Device class | Class II |
| Regulation | 21 CFR 868.5270 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BZE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 219 |
| 2018 | 1 | 290 |
| 2021 | 1 | 245 |
| 2023 | 1 | 268 |
| 2024 | 2 | 128 |
| 2025 | 1 | 287 |
| 2026 | 2 | 264 |
Compare with all 510(k) review times · Search every BZE clearance
Top BZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Fisher & Paykel Healthcare, Ltd. | 3 | 2012-12-06 |
| Medline Industries, LP | 2 | 2026-03-25 |
| Carefusion, Inc. | 2 | 2016-07-07 |
| Plastiflex Group NV | 2 | 2016-03-24 |
| Respironics, Inc. | 2 | 2014-11-14 |
33 more applicants have BZE clearances. See the full list in Caduvo.
Most recent BZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252066 | Vincent Healthcare Products Limited | inspired Heated Breathing Circuit (510-008); inspired Heated Breathing Circuit (510-009); inspired Auto-feed Humidification Chamber (VHC10); inspired Auto-feed Humidification Chamber (VHC20) | 2026-06-18 | 352 |
| K253322 | Medline Industries, LP | Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78 Infant Circuit, HUD99060KIT / Dri-Tech with 78 Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60 Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44 Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) | 2026-03-25 | 176 |
| K243244 | Guangdong Eda Technology Co., Ltd. | Heated Breathing Tube | 2025-07-25 | 287 |
| K241268 | Exceleron Medical | Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) | 2024-08-02 | 88 |
| K234032 | Medline Industries, LP | Hudson RCI Dri-Tech Breathing Circuits; HUD99035/Dri-Tech Adult Circuit; HUD99035KIT/Dri-Tech Adult Circuit Kit; HUD99098KIT/Single Limb Adult Dri-Tech Kit; HUD99098KITF/Single Limb Adult Dri-Tech Filter Kit; HUD900/Dri-Tech Ventilator Accessory; HUD901/Dri-Tech Ventilator Accessory Extension Line | 2024-06-04 | 167 |
Recalls for BZE devices
7 product recalls in 4 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2025-04-10.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code BZE?
BZE is the FDA product code for heater, breathing system w/wo controller (not humidifier or nebulizer. It is a Class II device, regulated under 21 CFR 868.5270 and reviewed by the Anesthesiology panel.
What device class is BZE?
Class II, regulation 21 CFR 868.5270. Typical premarket route: 510(k).
How long does a 510(k) take for product code BZE?
Across 46 cleared submissions the average was 193 days from receipt to decision (median 174).
Which companies have the most BZE clearances?
Fisher & Paykel Healthcare, Ltd. (3); Medline Industries, LP (2); Carefusion, Inc. (2); Plastiflex Group NV (2); Respironics, Inc. (2).
Have BZE devices been recalled?
Yes: 7 product recalls across 4 recall events; the most recent began 2025-04-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BZE
- Run a recall and safety report across every BZE manufacturer
- Watch product code BZE 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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