70 ML Reservoir Bag and Administration Sets
FDA 510(k) K860222 · Prn Services, Inc.
510(k) numberK860222
Submission
- Device name
- 70 ML Reservoir Bag and Administration Sets
- Applicant
- Prn Services, Inc.
Royal Oak, MI, US - Received
- January 22, 1986
- Decision date
- June 9, 1986
- 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 |
More from Deka Research and Development Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K943206 | Various TubingFPK · Traditional | 03/09/1995SE |
| K902330 | E-Z Flo + SetFPA · Traditional | 09/21/1990SE |
| K897065 | Port Infusion Set (Pis) Infusion Set (Is)FPA · Traditional | 02/16/1990SE |
| K882598 | 250 ML Bag W/Y Inject. & 12 Extension SetFRN · Traditional | 11/01/1988SE |
| K884053 | PRN Plus + Infusion SetFPA · Traditional | 10/31/1988SE |
| K875155 | 60 ML Reservoir Bag, Item #200KPE · Traditional | 02/16/1988SE |
Questions and answers
When was 70 ML Reservoir Bag and Administration Sets cleared by the FDA?
70 ML Reservoir Bag and Administration Sets (K860222) received a 510(k) decision of Substantially Equivalent on June 9, 1986, 138 days after the submission was received.
What is the product code of K860222?
The FDA product code is FRN – Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.