Deseret E-Z Set Infusion Set
FDA 510(k) K821750 · Warner-Lambert Co.
510(k) numberK821750
Submission
- Device name
- Deseret E-Z Set Infusion Set
- Applicant
- Warner-Lambert Co.
Walker, MI, US - Received
- June 15, 1982
- Decision date
- July 2, 1982
- 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 |
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| 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 |
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Questions and answers
When was Deseret E-Z Set Infusion Set cleared by the FDA?
Deseret E-Z Set Infusion Set (K821750) received a 510(k) decision of Substantially Equivalent on July 2, 1982, 17 days after the submission was received.
What is the product code of K821750?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.