FDA product code BSP: Needle, Conduction, Anesthetic (W/Wo Introducer)
BSP is the FDA product code for needle, conduction, anesthetic (w/wo introducer). It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel. FDA has cleared 152 510(k) submissions under BSP, 9 in the last five years, from 82 different applicants. The average 510(k) review took 185 days (median 154); 126 days on average over the last three years. FDA has posted 17 recalls for BSP devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Needle, Conduction, Anesthetic (W/Wo Introducer) |
| Device class | Class II |
| Regulation | 21 CFR 868.5150 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BSP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 195 |
| 2018 | 8 | 257 |
| 2019 | 2 | 240 |
| 2020 | 3 | 272 |
| 2021 | 3 | 204 |
| 2022 | 2 | 380 |
| 2024 | 3 | 88 |
| 2025 | 4 | 164 |
Compare with all 510(k) review times · Search every BSP clearance
Top BSP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| PAJUNK GmbH Medizintechnologie | 13 | 2025-07-01 |
| Pajunk GmbH | 8 | 2012-02-29 |
| B.Braun Medical, Inc. | 5 | 2014-06-27 |
| Epimed International, Inc. | 5 | 2006-02-17 |
| Holgrath Medical Technologies, Inc. | 5 | 1995-07-25 |
77 more applicants have BSP clearances. See the full list in Caduvo.
Most recent BSP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243690 | PAJUNK GmbH Medizintechnologie | SonoMSK | 2025-07-01 | 214 |
| K243682 | PAJUNK GmbH Medizintechnologie | SonoPlex STIM; SonoPlex II | 2025-06-27 | 210 |
| K250774 | PAJUNK GmbH Medizintechnologie | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | 2025-06-25 | 103 |
| K243525 | PAJUNK GmbH Medizintechnologie | SonoTAP and SonoTAP II | 2025-03-24 | 130 |
| K241953 | PAJUNK GmbH Medizintechnologie | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | 2024-11-22 | 142 |
Recalls for BSP devices
17 product recalls in 13 recall events; 1 initiated in the last five years and 4 still open. Most recent: 2026-04-21.
| Year | Recalls |
|---|---|
| 2019 | 4 |
| 2020 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BSP?
BSP is the FDA product code for needle, conduction, anesthetic (w/wo introducer). It is a Class II device, regulated under 21 CFR 868.5150 and reviewed by the Anesthesiology panel.
What device class is BSP?
Class II, regulation 21 CFR 868.5150. Typical premarket route: 510(k).
How long does a 510(k) take for product code BSP?
Across 152 cleared submissions the average was 185 days from receipt to decision (median 154).
Which companies have the most BSP clearances?
PAJUNK GmbH Medizintechnologie (13); Pajunk GmbH (8); B.Braun Medical, Inc. (5); Epimed International, Inc. (5); Holgrath Medical Technologies, Inc. (5).
Have BSP devices been recalled?
Yes: 17 product recalls across 13 recall events; the most recent began 2026-04-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BSP
- Run a recall and safety report across every BSP manufacturer
- Watch product code BSP 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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