FDA product code PWH: Administrations Sets With Neuraxial Connectors
PWH is the FDA product code for administrations sets with neuraxial connectors. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel. FDA has cleared 4 510(k) submissions under PWH, 1 in the last five years, from 3 different applicants. The average 510(k) review took 307 days (median 304).
Definition
The connector for neuraxial applications is intended to facilitate ANSI/AAMI/ISO 80369-6:2016 compliant neuraxial specific connections.
Classification
| Field | Value |
|---|---|
| Device name | Administrations Sets With Neuraxial Connectors |
| Device class | Class II |
| Regulation | 21 CFR 880.5440 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for PWH
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 346 |
| 2018 | 1 | 261 |
| 2021 | 1 | 179 |
| 2023 | 1 | 441 |
Compare with all 510(k) review times · Search every PWH clearance
Top PWH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smiths Medical Asd, Inc. | 2 | 2018-05-17 |
| Care Fusion | 1 | 2023-07-21 |
| Baxter Healthcare Corporation | 1 | 2021-11-23 |
Most recent PWH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221319 | Care Fusion | BD Alaris Pump Epidural Infusion Set | 2023-07-21 | 441 |
| K211649 | Baxter Healthcare Corporation | PCEA Syringe Set | 2021-11-23 | 179 |
| K172592 | Smiths Medical Asd, Inc. | CADD Yellow High Volume Administration Set with NRFit connector | 2018-05-17 | 261 |
| K162219 | Smiths Medical Asd, Inc. | CADD® Infusion Disposables Portfolio with NRFit connectors | 2017-07-20 | 346 |
Recalls for PWH devices
openFDA lists no recalls for product code PWH.
Frequently asked questions
What is FDA product code PWH?
PWH is the FDA product code for administrations sets with neuraxial connectors. It is a Class II device, regulated under 21 CFR 880.5440 and reviewed by the General Hospital panel.
What device class is PWH?
Class II, regulation 21 CFR 880.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code PWH?
Across 4 cleared submissions the average was 307 days from receipt to decision (median 304).
Which companies have the most PWH clearances?
Smiths Medical Asd, Inc. (2); Care Fusion (1); Baxter Healthcare Corporation (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PWH
- Run a recall and safety report across every PWH manufacturer
- Watch product code PWH 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.
All General Hospital product codes · FDA product code lookup · 510(k) database search · 510(k) review times