Models IDA-2 Plus and IPT-1
FDA 510(k) K961862 · Bio-Tek Instruments, Inc.
510(k) numberK961862
Submission
- Device name
- Models IDA-2 Plus and IPT-1
- Applicant
- Bio-Tek Instruments, Inc.
Winooski, VT, US - Received
- May 14, 1996
- Decision date
- February 26, 1997
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- FRN – Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) InjectionFRN · Special | Deka Research & Development Corp. | 03/11/2025SE |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRN · Traditional | Deka Research and Development Corp. | 01/16/2025SE |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K973609 | IDA-4 and Ipt-McFRN · Traditional | 12/18/1997ST |
| K971273 | Index 2E, Index 2F, Index 2EF, Cardiosat 100E, Cardiosat 100F, Cardiosat 100EFDQA · Traditional | 10/08/1997SE |
| K954391 | Models QED-6, 6M and 6H Defibrillator Analyzer with Optional Universal Pacemaker Load…DRL · Traditional | 11/17/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | 10/19/1995SE |
| K950104 | ELX800 and EL800 Automated Microplate ReadersJJQ · Traditional | 03/21/1995SE |
| K942923 | Ceres 900C & Ceres UV900CJJQ · Traditional | 02/06/1995SE |
| K944257 | Lionheart 3 Multi-Parameter SimulatorDRT · Traditional | 09/21/1994SE |
| K933519 | Index SPO2 SimulatorDQA · Traditional | 09/01/1994SE |
| K933548 | Els 1000JJE · Traditional | 10/29/1993SE |
Questions and answers
When was Models IDA-2 Plus and IPT-1 cleared by the FDA?
Models IDA-2 Plus and IPT-1 (K961862) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on February 26, 1997, 288 days after the submission was received.
What is the product code of K961862?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.