KZD · Infusor, Pressure, For I.V. Bags
General Hospital · 21 CFR 880.5420 · Class 1
Overview
| Product Code | KZD |
|---|---|
| Device Name | Infusor, Pressure, For I.V. Bags |
| Regulation | 21 CFR 880.5420 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.
Recent Cleared Devices (20 of 35)
Showing 20 most recent of 35 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K974074 | INFUSION DYNAMICS POWER INFUSER | Infusion Dynamics, Inc. | Feb 17, 1998 | SESE |
| K973843 | MSI PRESSURE INFUSOR | Smith Assoc. | Oct 29, 1997 | SESE |
| K953290 | OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP | Olympus America, Inc. | Oct 7, 1995 | SESE |
| K951988 | PRESSURIZER | Promedic, Inc. | Jun 14, 1995 | SESE |
| K942933 | PRESSURE INFUSION CUFF | Circulatory Technology, Inc. | Aug 25, 1994 | SESE |
| K930012 | KAWASUMI LABORATORIES K-CUFF | Kawasumi Laboratories Co., Ltd. | Dec 14, 1993 | SESE |
| K921168 | ALLEN INFUSION PUMP MODEL 3000 AND IRRIGATION 2000 | Allen Medical Systems, Inc. | Apr 21, 1993 | SESE |
| K913751 | PRESSURE INFUSER | Biomedical Dynamics, Inc. | Jan 9, 1992 | SESE |
| K910926 | TECNADYNE SURGI-SQUEEZE INFUSION PUMP | Tecnadyne Scientific, Inc. | Aug 2, 1991 | SESE |
| K911216 | INFUSABLE | Biomedical Dynamics, Inc. | Jul 22, 1991 | SESE |
| K904484 | BAXTER SINGLE PATIENT USE PRESSURE INFUSOR | Tecnadyne Scientific, Inc. | Oct 26, 1990 | SESE |
| K901225 | LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) | Abbott Laboratories | Aug 23, 1990 | SESE |
| K894927 | SURGI SQUEEZ | Ethox Corp. | Sep 11, 1989 | SESE |
| K881977 | PRESSURE INFUSOR | Primrose Medical, Inc. | Jul 29, 1988 | SESE |
| K874454 | IV-PUSH, CONSTANT INFUSION PUMP | Medical Products Search, Inc. | Nov 6, 1987 | SESE |
| K861977 | BIOMEDICAL DYNAMICS DISPOSABLE PRESSURE INFUSOR | Biomedical Dynamics, Inc. | Jul 15, 1986 | SESE |
| K854807 | LIFE PAC | Lifemed Technologies, Inc. | Apr 15, 1986 | SESE |
| K860084 | PRESSURE INFUSOR #1900 | Pa Medical Corp. | Mar 18, 1986 | SESE |
| K855054 | THE WOOD PUMP 'OLE RED' | T.C. Retigo, Inc. | Mar 18, 1986 | SESE |
| K851904 | DATA TRAC ANESTHESIOLOGY RECORDER | Datascope Corp. | May 10, 1985 | SESE |
Top Applicants
- Biomedical Dynamics, Inc. — 3 clearances
- Tecnadyne Scientific, Inc. — 2 clearances
- Travenol Laboratories, S.A. — 2 clearances
- Abbott Laboratories — 1 clearance
- Allen Medical Systems, Inc. — 1 clearance
