FDA product code BSN: Filter, Conduction, Anesthetic
BSN is the FDA product code for filter, conduction, anesthetic. It is a Class II device, regulated under 21 CFR 868.5130 and reviewed by the Anesthesiology panel. FDA has cleared 9 510(k) submissions under BSN, from 6 different applicants. The average 510(k) review took 174 days (median 121). FDA has posted 1 recall for BSN devices.
Classification
| Field | Value |
|---|---|
| Device name | Filter, Conduction, Anesthetic |
| Device class | Class II |
| Regulation | 21 CFR 868.5130 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BSN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 94 |
Compare with all 510(k) review times · Search every BSN clearance
Top BSN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Millipore Corp. | 3 | 2003-01-17 |
| Arbor Technologies, Inc. | 2 | 1997-04-04 |
| PAJUNK GmbH Medizintechnologie | 1 | 2019-06-17 |
| Merck Millipore , Ltd. | 1 | 2014-03-27 |
| Smiths Medical Asd, Inc. | 1 | 2009-03-04 |
1 more applicants have BSN clearances. See the full list in Caduvo.
Most recent BSN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190663 | PAJUNK GmbH Medizintechnologie | Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 | 2019-06-17 | 94 |
| K133004 | Merck Millipore , Ltd. | VENTED MILLEX -GV, CATHIVEX -GV | 2014-03-27 | 183 |
| K083451 | Smiths Medical Asd, Inc. | PORTEX EPIDURAL FILTER, MODEL 100/386/010, VARIOUS STANDARD AND CUSTOM TRAYS | 2009-03-04 | 103 |
| K023892 | Millipore Corp. | MILLEX VV, GV, AND HV SYRINGE FILTER UNITS | 2003-01-17 | 56 |
| K013988 | Millipore Corp. | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R | 2002-04-04 | 121 |
Recalls for BSN devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2009-11-25.
Frequently asked questions
What is FDA product code BSN?
BSN is the FDA product code for filter, conduction, anesthetic. It is a Class II device, regulated under 21 CFR 868.5130 and reviewed by the Anesthesiology panel.
What device class is BSN?
Class II, regulation 21 CFR 868.5130. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSN?
Across 9 cleared submissions the average was 174 days from receipt to decision (median 121).
Which companies have the most BSN clearances?
Millipore Corp. (3); Arbor Technologies, Inc. (2); PAJUNK GmbH Medizintechnologie (1); Merck Millipore , Ltd. (1); Smiths Medical Asd, Inc. (1).
Have BSN devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2009-11-25.
Next steps
- Run an FDA pathway report with predicate devices for product code BSN
- Run a recall and safety report across every BSN manufacturer
- Watch product code BSN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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