I.V. Tubing Organizer
FDA 510(k) K790901 · Acumed Instruments Corp.
510(k) numberK790901
Submission
- Device name
- I.V. Tubing Organizer
- Applicant
- Acumed Instruments Corp.
Mchenry, IL, US - Received
- May 10, 1979
- Decision date
- June 27, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FPA – Set, Administration, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5440
- Specialty
- General Hospital
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| K252543 | AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072…FPA · Traditional | Amsino International, Inc. | 05/04/2026SE |
| K251375 | PuraCath Firefly Needleless Connector IT (9005)FPA · Traditional | Puracath Medical, Inc. | 02/12/2026SE |
| K251257 | nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Free…FPA · Traditional | Np Medical | 12/04/2025SE |
| K250325 | BD Alaris Pump Infusion SetFPA · Traditional | Carefusion (Bd) | 10/30/2025SE |
| K251814 | EZ IV Administration SetFPA · Traditional | Epic Medical Pte. , Ltd. | 08/29/2025SE |
| K251854 | SteadiSet infusion setFPA · Abbreviated | Tandem Diabetes Care | 08/06/2025SE |
| K243841 | Sparta Infusion Set for InsulinFPA · Traditional | Deka Research and Development | 08/01/2025SE |
| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K863627 | Micro Surgical Drill System · Traditional | 10/02/1986SE |
| K853660 | Micro Surgical Drill System · Traditional | 09/24/1985SE |
| K853659 | Powered Irrigation for Micro Surgical Drill · Traditional | 09/24/1985SE |
| K853658 | Burs for Micro Surgical Drill SystemGFF · Traditional | 09/24/1985SE |
| K791891 | Acu-Med Red Miser Hemothorax Blood Coll.CAC · Traditional | 12/05/1979SE |
| K791399 | Acu-Alert · Traditional | 10/11/1979SE |
| K791400 | Gastric Lavage Kit-DisposableGBQ · Traditional | 08/16/1979SE |
Questions and answers
When was I.V. Tubing Organizer cleared by the FDA?
I.V. Tubing Organizer (K790901) received a 510(k) decision of Substantially Equivalent on June 27, 1979, 48 days after the submission was received.
What is the product code of K790901?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.