P/N 9320 Low Flow Air/Oxygen Microblender
by Bird Products Corp. 510(k)
Active
510(k) K883038
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK883038 | Date16 Nov 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZR
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5330
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The P/N 9320 Low Flow Air/Oxygen Microblender is a Mixer, Breathing Gases, Anesthesia Inhalation, designed to blend air and oxygen gases for precise delivery in controlled environments. It ensures accurate gas mixture ratios, critical for anesthesia and respiratory support applications where consistent oxygen concentration is required.
This device is intended for single-use or reusable settings, depending on facility protocols, and operates within a low-flow range of 3–30 LPM for air and 0–30 LPM with bleed. It is classified as FDA Class II and holds a 510(k) clearance (K883038) under the Anesthesiology advisory committee, with regulatory compliance under 21 CFR 868.5330. Storage and handling must adhere to manufacturer guidelines to maintain functionality and sterility.
Other devices from Bird Products Corp.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the P/N 9320 Low Flow Air/Oxygen Microblender in clinical settings?
The P/N 9320 Low Flow Air/Oxygen Microblender is designed to blend air and oxygen gases with precision for controlled delivery in anesthesia and respiratory support applications. It ensures accurate gas mixture ratios, which are critical for maintaining consistent oxygen concentrations during procedures where stable gas flow is essential.
Can this device be reused, or is it intended for single-use only?
The P/N 9320 is intended for either single-use or reusable settings, depending on facility protocols. While it is not explicitly restricted to single-use, proper cleaning, maintenance, and adherence to manufacturer guidelines are required if reused to ensure functionality and safety.
What flow rate range does this microblender support, and how does that affect its use?
The device operates within a low-flow range of 3–30 LPM for air and 0–30 LPM with bleed, making it suitable for applications requiring precise, controlled gas delivery in anesthesia or respiratory therapy. This range ensures compatibility with low-flow systems commonly used in clinical settings.
How should storage and handling be managed to maintain the device’s functionality and sterility?
Storage and handling must strictly follow the manufacturer’s guidelines to preserve functionality and sterility. Since the device can be used in both single-use and reusable settings, proper cleaning protocols (if reused) and environmental controls (if sterile) are essential to prevent contamination or performance degradation.
What regulatory pathway was followed for FDA clearance, and what does that mean for its use?
The P/N 9320 received FDA 510(k) clearance (K883038) under the Anesthesiology advisory committee, classified as FDA Class II. This means it was determined to be substantially equivalent to a legally marketed device and complies with 21 CFR 868.5330, ensuring it meets established safety and performance standards for anesthesia-related gas mixing.