FDA product code KZE: Injector, Fluid, Non-Electrically Powered
KZE is the FDA product code for injector, fluid, non-electrically powered. It is a Class II device, regulated under 21 CFR 880.5430 and reviewed by the General Hospital panel. FDA has cleared 53 510(k) submissions under KZE, from 29 different applicants. The average 510(k) review took 148 days (median 89). FDA has posted 1 recall for KZE devices.
Classification
| Field | Value |
|---|---|
| Device name | Injector, Fluid, Non-Electrically Powered |
| Device class | Class II |
| Regulation | 21 CFR 880.5430 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every KZE clearance
Top KZE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bioject, Inc. | 7 | 2009-04-02 |
| Derata Corp. | 6 | 1988-10-31 |
| Equidyne Systems, Inc. | 5 | 2002-09-05 |
| Pharmajet, Inc. | 3 | 2011-07-27 |
| Medi-Ject Corp. | 3 | 1999-04-23 |
24 more applicants have KZE clearances. See the full list in Caduvo.
Most recent KZE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K121270 | Bioject Medical Technologies, Inc. | BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEM | 2012-07-19 | 84 |
| K111517 | Pharmajet, Inc. | PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATI | 2011-07-27 | 55 |
| K110456 | Pharmajet, Inc. | PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM | 2011-03-02 | 14 |
| K090959 | D'Antonio Consultants International, Inc. (Dci) | LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA | 2009-12-24 | 262 |
| K090003 | Bioject, Inc. | ZETAJET | 2009-04-02 | 90 |
Recalls for KZE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2010-06-01.
Frequently asked questions
What is FDA product code KZE?
KZE is the FDA product code for injector, fluid, non-electrically powered. It is a Class II device, regulated under 21 CFR 880.5430 and reviewed by the General Hospital panel.
What device class is KZE?
Class II, regulation 21 CFR 880.5430. Typical premarket route: 510(k).
How long does a 510(k) take for product code KZE?
Across 53 cleared submissions the average was 148 days from receipt to decision (median 89).
Which companies have the most KZE clearances?
Bioject, Inc. (7); Derata Corp. (6); Equidyne Systems, Inc. (5); Pharmajet, Inc. (3); Medi-Ject Corp. (3).
Have KZE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2010-06-01.
Next steps
- Run an FDA pathway report with predicate devices for product code KZE
- Run a recall and safety report across every KZE manufacturer
- Watch product code KZE 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.
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