Filter, Conduction, Anesthetic
The Filter, Conduction, Anesthetic is a device used within anesthesia breathing circuits to filter particulates, bacteria, or viruses from inspired and expired gases, reducing cross-contamination risks. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BSN, regulated under 21 CFR 868.5130 in the Anesthesiology specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- BSN
- Device Class
- FDA class 2
- Regulation Number
- 868.5130
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190663 | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | Jun 17, 2019 | Substantially Equivalent | PAJUNK GmbH Medizintechnologie |
| K133004 | VENTED MILLEX -GV, CATHIVEX -GV | Mar 27, 2014 | Substantially Equivalent | Merck Millipore , Ltd. |
| K083451 | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | Mar 04, 2009 | Substantially Equivalent | Smiths Medical Asd, Inc. |
| K023892 | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | Jan 17, 2003 | Substantially Equivalent | Millipore Corp. |
| K013988 | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | Apr 04, 2002 | Substantially Equivalent | Millipore Corp. |
| K963717 | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) | Jun 10, 1997 | Substantially Equivalent | Millipore Corp. |
| K960928 | SYRINGEFILTER | Apr 04, 1997 | Substantially Equivalent | Arbor Technologies, Inc. |
| K902666 | ANESTHESIA CONDUCTION FILTER | Apr 23, 1991 | Substantially Equivalent | Arbor Technologies, Inc. |
| K780519 | FILTER TUBE | May 09, 1978 | Substantially Equivalent | Jelco Laboratories |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.