Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440) → PWH — Administrations Sets With Neuraxial Connectors

# PWH · Administrations Sets With Neuraxial Connectors

_General Hospital · 21 CFR 880.5440 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH

## Overview

- **Product Code:** PWH
- **Device Name:** Administrations Sets With Neuraxial Connectors
- **Regulation:** [21 CFR 880.5440](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5440)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

## Classification Rationale

Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

## Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K221319](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH/K221319.md) | BD Alaris™ Pump Epidural Infusion Set | Care Fusion | Jul 21, 2023 | SESE |
| [K211649](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH/K211649.md) | PCEA Syringe Set | Baxter Healthcare Corporation | Nov 23, 2021 | SESE |
| [K172592](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH/K172592.md) | CADD Yellow High Volume Administration Set with NRFit connector | Smiths Medical Asd, Inc. | May 17, 2018 | SESE |
| [K162219](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH/K162219.md) | CADD® Infusion Disposables Portfolio with NRFit™ connectors | Smiths Medical Asd, Inc. | Jul 20, 2017 | SESE |

## Top Applicants

- Smiths Medical Asd, Inc. — 2 clearances
- Baxter Healthcare Corporation — 1 clearance
- Care Fusion — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/PWH)

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