Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K202459 FDA 510(k)
- FDA Product Code
- CAH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5260 FDA 510(k)
- Regulation Number
- 868.5260 FDA 510(k)
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The device is a bacterial breathing-circuit filter designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems. It is classified as a Filter, Bacterial, Breathing-Circuit under FDA product code CAH and regulation number 868.5260.
The device may be used on the patient side of the ventilator anaesthetic device. It is supplied as a single-use filter with conical fittings in accordance with ISO standard for safe connection security and is provided in a clear housing for easy inspection. Authorisations include FDA 510(k) clearance under K-number K202459, with a traditional clearance decision based on substantial equivalence to a predicate device.
Frequently asked questions
What is the Bact-Trap Filter intended to do in a breathing circuit?
The Bact-Trap Filter is designed to reduce possible airborne or liquid-borne cross contamination with micro-organisms and particulate matter via anaesthetic or ventilator breathing systems, helping to protect both the patient and equipment from microbial transfer during use.
How is the Bact-Trap Filter supplied and what does that mean for its use?
The device is supplied as a single-use filter, meaning it is intended for one patient and one procedure only, and should be discarded after use to prevent cross-contamination and ensure optimal filtration performance.
What regulatory pathway was used for the Bact-Trap Filter, and what does that indicate about its clearance?
The Bact-Trap Filter received FDA 510(k) clearance under K-number K202459 through a traditional clearance process based on substantial equivalence to a predicate device, meaning it was found to be as safe and effective as a legally marketed device.
What design features does the Bact-Trap Filter have to ensure safe and effective use?
The filter features conical fittings that comply with ISO standards for secure connections and is housed in a clear casing, allowing for visual inspection to confirm proper placement and integrity before and during use.
Where can the Bact-Trap Filter be positioned in a ventilator or anaesthetic system?
The device may be used on the patient side of the ventilator or anaesthetic device, placing it between the patient and the breathing circuit to filter exhaled or inhaled gases and reduce the risk of microbial transfer.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME ..., Bact-Trap Mini, Basic - Pharma Systems, Products - Pharma Systems
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202459 | Class II | Active |
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Manufacturer
- Manufacturer
- Pharma System AB
Sources (1)
- FDA 510(k) K202459 24 fields · synced Sep 19, 2026