BSN
9 FDA 510(k) clearances · Product code
121 daysmedian time to decision
393 days90th percentile
9clearances measured
FDA profile
- Official device name
- Filter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5130
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2012: 88 · 2022: 23 · 2023: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 (K190663) | PAJUNK GmbH Medizintechnologie | 2019-06-17 |
| VENTED MILLEX -GV, CATHIVEX -GV (K133004) | Merck Millipore , Ltd. | 2014-03-27 |
| PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS (K083451) | Smiths Medical Asd, Inc. | 2009-03-04 |
| MILLEX VV, GV, AND HV SYRINGE FILTER UNITS (K023892) | Millipore Corp. | 2003-01-17 |
| MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R (K013988) | Millipore Corp. | 2002-04-04 |
| MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) (K963717) | Millipore Corp. | 1997-06-10 |
| SYRINGEFILTER (K960928) | Arbor Technologies, Inc. | 1997-04-04 |
| ANESTHESIA CONDUCTION FILTER (K902666) | Arbor Technologies, Inc. | 1991-04-23 |
| FILTER TUBE (K780519) | Jelco Laboratories | 1978-05-09 |
Track BSN automatically
Every clearance here is in the API, with alerts when new ones post.