NeumoFilt Ergo/Neumo Filt BiteOn
by Medical Respiratory Devices S.L. EUDAMED510(k)
Active
510(k) K142303
Overview
The NeumoFilt Ergo and NeumoFilt BiteOn are respiratory filter systems designed to remove contaminants from inhaled gases during anesthesia. These devices are classified as spirometers and are intended for use in anesthesia circuits to enhance patient safety by filtering airborne particles and pathogens.
These devices are supplied as single-use, non-sterile components for use in controlled clinical environments such as operating rooms. They are classified under FDA regulation 868.1840 and have received FDA 510(k) clearance and MDR authorization. The NeumoFilt Ergo and NeumoFilt BiteOn are intended for reusable or disposable use depending on facility protocols, with no specific MRI safety restrictions noted.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK142303 | Date20 Nov 2014 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BZG
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.1840
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Medical Respiratory Devices S.L.
Questions
Are the NeumoFilt Ergo and NeumoFilt BiteOn filters intended for single-use only, or can they be reused under certain conditions?
The NeumoFilt Ergo and NeumoFilt BiteOn are supplied as single-use components, but their reuse depends on facility protocols. The device description explicitly states they are designed for use in controlled clinical environments like operating rooms, where facilities may choose to reuse them if properly validated and maintained. There is no explicit restriction against reuse, so hospitals can follow their own guidelines for reprocessing.
What is the primary purpose of the NeumoFilt Ergo and NeumoFilt BiteOn in an anesthesia circuit?
The NeumoFilt Ergo and NeumoFilt BiteOn are respiratory filter systems intended to remove airborne contaminants, including particles and pathogens, from inhaled gases during anesthesia. This enhances patient safety by filtering the gases before they reach the patient, reducing the risk of infection or exposure to harmful substances.
Are these filters sterile when supplied, and if not, what precautions should be taken before use?
The NeumoFilt Ergo and NeumoFilt BiteOn are supplied as non-sterile components. Since they are intended for use in controlled clinical environments like operating rooms, facilities should follow standard aseptic techniques, such as cleaning hands, wearing gloves, and using sterile packaging or procedures if needed, to ensure proper hygiene before use.
What regulatory pathways have these devices undergone, and which committees or authorities were involved?
The NeumoFilt Ergo and NeumoFilt BiteOn have received FDA 510(k) clearance under the traditional review pathway, with a decision described as *Substantially Equivalent* by the Anesthesiology (AN) Advisory Committee. They are also authorized under the EU Medical Device Regulation (MDR). The device falls under FDA product code BZG and regulation 868.1840, classified as a spirometer.
Do these filters have any restrictions regarding use in MRI environments?
The device description does not mention any MRI safety restrictions for the NeumoFilt Ergo or NeumoFilt BiteOn. However, since they are part of an anesthesia circuit, facilities should verify compatibility with their specific MRI protocols and equipment to ensure safe use in those environments.