FDA product code BSO: Catheter, Conduction, Anesthetic
BSO is the FDA product code for catheter, conduction, anesthetic. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel. FDA has cleared 75 510(k) submissions under BSO, 3 in the last five years, from 49 different applicants. The average 510(k) review took 162 days (median 144); 272 days on average over the last three years. FDA has posted 119 recalls for BSO devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Conduction, Anesthetic |
| Device class | Class II |
| Regulation | 21 CFR 868.5120 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BSO
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 211 |
| 2018 | 2 | 256 |
| 2019 | 2 | 194 |
| 2020 | 2 | 150 |
| 2023 | 2 | 158 |
| 2025 | 1 | 272 |
Compare with all 510(k) review times · Search every BSO clearance
Top BSO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B.Braun Medical, Inc. | 6 | 2023-09-15 |
| Epimed International, Inc. | 4 | 2020-04-27 |
| PAJUNK GmbH Medizintechnologie | 3 | 2018-05-03 |
| I-Flow Corp. | 3 | 2006-11-21 |
| Baxter Healthcare Corp | 3 | 1995-03-24 |
44 more applicants have BSO clearances. See the full list in Caduvo.
Most recent BSO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241410 | Jmt Co., Ltd. | EDEN ControlCath | 2025-02-13 | 272 |
| K231242 | B.Braun Medical, Inc. | Perifix FX Catheter; Contiplex FX Catheter | 2023-09-15 | 137 |
| K230603 | Teleflex Medical | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) | 2023-08-30 | 180 |
| K193664 | Hk Surgical | SubQKath Catheter and Needle Set | 2020-09-09 | 253 |
| K200624 | Epimed International, Inc. | Percutaneous Introducer | 2020-04-27 | 48 |
Recalls for BSO devices
119 product recalls in 11 recall events; 2 initiated in the last five years and 3 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2018 | 93 |
| 2019 | 5 |
| 2020 | 13 |
| 2021 | 1 |
| 2026 | 2 |
Frequently asked questions
What is FDA product code BSO?
BSO is the FDA product code for catheter, conduction, anesthetic. It is a Class II device, regulated under 21 CFR 868.5120 and reviewed by the Anesthesiology panel.
What device class is BSO?
Class II, regulation 21 CFR 868.5120. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSO?
Across 75 cleared submissions the average was 162 days from receipt to decision (median 144).
Which companies have the most BSO clearances?
B.Braun Medical, Inc. (6); Epimed International, Inc. (4); PAJUNK GmbH Medizintechnologie (3); I-Flow Corp. (3); Baxter Healthcare Corp (3).
Have BSO devices been recalled?
Yes: 119 product recalls across 11 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BSO
- Run a recall and safety report across every BSO manufacturer
- Watch product code BSO 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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