National Med Care Infusion Pump Adm Set #95-0001-8
FDA 510(k) K853134 · Erika, Inc.
510(k) numberK853134
Submission
- Device name
- National Med Care Infusion Pump Adm Set #95-0001-8
- Applicant
- Erika, Inc.
Rockleigh, NJ, US - Received
- July 26, 1985
- Decision date
- November 6, 1985
- 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 |
| K252015 | FreedomEdge Infusion System; High-Flo SubQ Needle Set; Precision Flow Rate TubingFRN · Traditional | Koru Medical Systems, Inc. | 01/28/2026SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | Baxter Healthcare Corporation | 07/28/2025SE |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K852310 | Naturalyte Bicarbonate Concentrate-Dry PackFKQ · Traditional | 07/26/1985SE |
| K852309 | Erika Art Li, 3-9621-8, 22-6, 23-4 & Ven 9714-1FJK · Traditional | 07/26/1985SE |
| K850866 | Toray Industries Filtryzer Hollow Fiber Kidney B1LKDI · Traditional | 04/03/1985SE |
| K850865 | Toray Industries Filtryzer Hollow Fiber Kidney B1-FJI · Traditional | 04/03/1985SE |
| K850655 | Toray Ind. Filtryzer Hollow Fiber Artif. Kidney B2FJI · Traditional | 03/07/1985SE |
| K850654 | Toray Indus. Filtryzer Hollow Fiber Artificial KidFJI · Traditional | 03/07/1985SE |
| K842436 | Erika Negative Press. Arterial BloodKOC · Traditional | 07/13/1984SE |
| K831176 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831175 | Filtryzer Hollow Fiber Artif. KidneyKOC · Traditional | 06/22/1984SE |
| K831174 | Filtryzer Hollow Fiber Artificial Kid-KOC · Traditional | 06/22/1984SE |
Questions and answers
When was National Med Care Infusion Pump Adm Set #95-0001-8 cleared by the FDA?
National Med Care Infusion Pump Adm Set #95-0001-8 (K853134) received a 510(k) decision of Substantially Equivalent on November 6, 1985, 103 days after the submission was received.
What is the product code of K853134?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.