Bowron Neonatal Incubator
by G.L. Bowron & Co., Ltd. 510(k)
Active
510(k) K922618
Overview
The Bowron Neonatal Incubator is a medical device classified as a neonatal incubator, designed to provide a controlled environment for premature or low-birth-weight infants. It maintains optimal temperature, humidity, and oxygen levels to support physiological stability, reduce infection risk, and promote safe growth in neonatal care settings. The device is engineered to accommodate varying infant sizes while ensuring minimal thermal stress and maximum comfort.
This incubator is intended for use in general hospital neonatal intensive care units (NICUs) and is supplied as a reusable medical device. It is not sterile upon delivery and must be cleaned and disinfected between uses according to facility protocols. The device adheres to FDA regulatory standards under 510(k) clearance (K922618) and is categorized under product code FMZ, with a classification of Class II. Storage and maintenance follow manufacturer guidelines to ensure proper functionality and compliance with medical device regulations.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922618 | Date19 Aug 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- Full name
- Bowron
- 510(k) Number
- FDA Product Code
- FMZ
- FDA applicant
- G.L. Bowron & Co. , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5400
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the Bowron Neonatal Incubator designed for?
The Bowron Neonatal Incubator is specifically engineered to create a controlled environment for premature or low-birth-weight infants in neonatal intensive care units (NICUs). It regulates temperature, humidity, and oxygen levels to maintain physiological stability, reduce infection risk, and ensure safe, comfortable growth. This makes it ideal for critical care settings where precise environmental control is essential for vulnerable newborns.
Is the Bowron Neonatal Incubator sterile when delivered?
No, the Bowron Neonatal Incubator is not sterile upon delivery. It is classified as a reusable medical device, meaning it must be thoroughly cleaned and disinfected between uses according to the facility’s established protocols. This ensures proper hygiene and compliance with medical device safety standards before each use.
How does the Bowron Neonatal Incubator accommodate different infant sizes?
The Bowron Neonatal Incubator is designed with adjustable features to accommodate varying infant sizes, from premature newborns to low-birth-weight babies. Its engineering prioritizes flexibility while minimizing thermal stress and maximizing comfort, ensuring a safe and adaptable environment for diverse neonatal care needs.
What regulatory standards does the Bowron Neonatal Incubator meet?
The Bowron Neonatal Incubator adheres to FDA regulatory standards and holds a 510(k) clearance under the classification of Class II (product code FMZ). This clearance confirms it is substantially equivalent to a legally marketed device and meets the requirements for general hospital use in neonatal intensive care settings.
How should the Bowron Neonatal Incubator be stored and maintained?
The Bowron Neonatal Incubator must be stored and maintained according to the manufacturer’s guidelines to ensure proper functionality and compliance. This includes regular cleaning, disinfection, and inspection to prevent wear or damage. Adhering to these protocols extends the device’s lifespan and ensures it operates safely and effectively in clinical environments.