Pressurizer
FDA 510(k) K951988 · Promedic, Inc.
510(k) numberK951988
Submission
- Device name
- Pressurizer
- Applicant
- Promedic, Inc.
Indianapolis, IN, US - Received
- April 27, 1995
- Decision date
- June 14, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KZD – Infusor, Pressure, For I.V. Bags
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5420
- Specialty
- General Hospital
Other 510(k)s with product code KZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974074 | Infusion Dynamics Power InfuserKZD · Traditional | Infusion Dynamics, Inc. | 02/17/1998SE |
| K973843 | Msi Pressure InfusorKZD · Traditional | Smith Assoc. | 10/29/1997SE |
| K953290 | Olympus Automatic Surgical Irrigation PumpKZD · Traditional | Olympus America, Inc. | 10/07/1995SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | Circulatory Technology, Inc. | 08/25/1994SE |
| K930012 | Kawasumi Laboratories K-CuffKZD · Traditional | Kawasumi Laboratories Co., Ltd. | 12/14/1993SE |
| K921168 | Allen Infusion Pump Model 3000 and Irrigation 2000KZD · Traditional | Allen Medical Systems, Inc. | 04/21/1993SE |
| K913751 | Pressure InfuserKZD · Traditional | Biomedical Dynamics, Inc. | 01/09/1992SE |
| K910926 | Tecnadyne Surgi-Squeeze Infusion PumpKZD · Traditional | Tecnadyne Scientific, Inc. | 08/02/1991SE |
| K911216 | InfusableKZD · Traditional | Biomedical Dynamics, Inc. | 07/22/1991SE |
| K904484 | Baxter Single Patient Use Pressure InfusorKZD · Traditional | Tecnadyne Scientific, Inc. | 10/26/1990SE |
More from Tecnadyne Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131889 | Eum 100PROOSP · Traditional | 04/23/2014SE |
| K112318 | Clearpath 24OCX · Traditional | 06/29/2012SE |
| K072756 | Non-Iv Adapter for Infant NG TubeKNT · Traditional | 12/19/2007SESK |
| K060497 | BabyairCAF · Traditional | 07/11/2006SE |
| K060842 | Revjet TurboCAF · Traditional | 06/21/2006SE |
| K052903 | Pediatric Feeding TubeKNT · Traditional | 11/09/2005SE |
| K031409 | Urinary CathetersGBM · Traditional | 06/17/2003SE |
| K024190 | Fenestrated Infusion CatheterFRN · Traditional | 03/17/2003SE |
| K023579 | Gas Sampling LinesCCK · Traditional | 01/28/2003SE |
| K020005 | Infant Feeding TubesKNT · Traditional | 07/16/2002SE |
Questions and answers
When was Pressurizer cleared by the FDA?
Pressurizer (K951988) received a 510(k) decision of Substantially Equivalent on June 14, 1995, 48 days after the submission was received.
What is the product code of K951988?
The FDA product code is KZD – Infusor, Pressure, For I.V. Bags, a Class I (low risk) device regulated under 21 CFR 880.5420.