Robinject
FDA 510(k) K864984 · International Medical Products, Inc.
510(k) numberK864984
Submission
- Device name
- Robinject
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- December 22, 1986
- Decision date
- June 29, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZE – Injector, Fluid, Non-Electrically Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5430
- Specialty
- General Hospital
Other 510(k)s with product code KZE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121270 | Bioject Needle-Free Injection Management SystemKZE · Traditional | Bioject Medical Technologies, Inc. | 07/19/2012SE |
| K111517 | Pharmajet Stratis 0.5 ML Needle-Free Injection System Model 501-01, Stratis Injector…KZE · Special | Pharmajet, Inc. | 07/27/2011SE |
| K110456 | Pharmajet 0.1 ML Intradermal Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 03/02/2011SE |
| K090959 | Lectrajet Needle-Free Injection System, Model: M3 RaKZE · Traditional | D'Antonio Consultants International, Inc. (Dci) | 12/24/2009SE |
| K090003 | ZetajetKZE · Abbreviated | Bioject, Inc. | 04/02/2009SE |
| K081532 | Pharmajet Needle-Free Injection SystemKZE · Traditional | Pharmajet, Inc. | 02/26/2009SE |
| K082138 | Airgent, Model AG7000010KZE · Traditional | Perfaction, Inc. | 01/23/2009SE |
| K060819 | Cool.Click 2KZE · Traditional | Medical House Products Limited | 06/16/2006SE |
| K051985 | Biovalve Mini-Ject Needlefree InjectorKZE · Special | Biovalve Technologies, Inc. | 08/17/2005SE |
| K050734 | Cool.ClickKZE · Traditional | Bioject, Inc. | 06/03/2005SE |
More from Bioject, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981003 | Rockwell Medical Supply, LLC Dri-Sate Acid Concentrate MixesKPO · Traditional | 06/16/1998SE |
| K973253 | Rockwell Medical Supply, LLC Concentrate Solutions for Acetate DialysateKPO · Traditional | 10/30/1997SE |
| K971053 | Rockwell Medical Supply,Llc. Bicarbonate Solution Concentrates for Bicarbonate DialysisKPO · Traditional | 06/16/1997SE |
| K920077 | Nikkiso NK PumpDWD · Traditional | 09/29/1993SE |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | 03/24/1993SE |
| K900755 | Digital Cuff PV GaugeBSK · Traditional | 04/26/1990SE |
| K863609 | Single-Patient Automatic Dialysis Unit Mod. DBB-22FKP · Traditional | 02/25/1987SE |
| K861539 | Nikkiso Infusion Pump Model PFA-02FRN · Traditional | 07/31/1986SE |
Questions and answers
When was Robinject cleared by the FDA?
Robinject (K864984) received a 510(k) decision of Substantially Equivalent on June 29, 1987, 189 days after the submission was received.
What is the product code of K864984?
The FDA product code is KZE – Injector, Fluid, Non-Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.5430.