Betatron IV System
FDA 510(k) K872774 · Cardiac Pacemakers, Inc.
510(k) numberK872774
Submission
- Device name
- Betatron IV System
- Applicant
- Cardiac Pacemakers, Inc.
St. Paul, MN, US - Received
- July 14, 1987
- Decision date
- January 5, 1988
- Decision
- Substantially Equivalent (SESE)
- 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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| K253703 | RemunityPRO+ Pump for Remodulin® (treprostinil) InjectionFRN · Traditional | Deka R&D Corp | 07/24/2026SE |
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| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
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| K242752 | MRidium 3870 MRI Infusion Pump System (3870)FRN · Traditional | Iradimed Corporation | 05/28/2025SE |
| K243855 | BD Alaris Infusion System with Guardrails Suite MXFRN · Traditional | Carefusion 303, Inc. | 04/25/2025SE |
| K242115 | Plum Duo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| K242114 | Plum Solo Precision IV PumpFRN · Traditional | Icu Medical, Inc. | 04/02/2025SE |
| 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 |
|---|---|---|
| K093969 | Acuity Break-Away Guide CatheterDQY · Special | 03/05/2010SE |
| K080154 | Acuity Universal CutterDQY · Special | 03/20/2008SE |
| K934727 | Replacement Parts for Cpi 6888 Lead TunnelerDWS · Traditional | 01/10/1994SE |
| K920601 | Astra T2, Astra T4, Astra T6DXY · Traditional | 10/28/1992SE |
| K912379 | PDT Carryall Transmitter, Various ModelsDXH · Traditional | 06/17/1991SE |
| K905674 | Lead StyletDRB · Traditional | 01/30/1991SE |
| K900498 | Modified Betatron IV Insulin Infusion SystemLZG · Traditional | 02/23/1990SE |
| K894738 | Model 6888 Lead TunnelerDWS · Traditional | 09/13/1989SE |
| K890785 | Astra T2, T3, T4, T6 Pulse Generators New PackageDXY · Traditional | 03/10/1989SE |
| K875147 | Torque Hex WrenchDTF · Traditional | 01/27/1988SE |
Questions and answers
When was Betatron IV System cleared by the FDA?
Betatron IV System (K872774) received a 510(k) decision of Substantially Equivalent on January 5, 1988, 175 days after the submission was received.
What is the product code of K872774?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.