← Product Code [KZD](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD) · K921168

# ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 (K921168)

_Allen Medical Systems, Inc. · KZD · Apr 21, 1993 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K921168

## Device Facts

- **Applicant:** Allen Medical Systems, Inc.
- **Product Code:** [KZD](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD.md)
- **Decision Date:** Apr 21, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5420
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K921168](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KZD/K921168)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com