Paradigm Sof-Set Ultimate QR, Models 317 and 318
FDA 510(k) K001832 · Minimed, Inc.
510(k) numberK001832
Submission
- Device name
- Paradigm Sof-Set Ultimate QR, Models 317 and 318
- Applicant
- Minimed, Inc.
Sylmar, CA, US - Received
- June 16, 2000
- Decision date
- August 18, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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| 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 |
|---|---|---|
| K031541 | Paradigmpal, Model MMT-7330LZG · Traditional | 11/18/2003SE |
| K031390 | Medtronic Minimed Paradigm Insulin Pump, Model MMT-712LGZ · Traditional | 07/23/2003SE |
| K030531 | Medtronic Minimed Paradigm Model 512 Insulin Pump and the BD Paradigm Link Glucose MeterLZG · Traditional | 06/17/2003SE |
| K021974 | Medtronic Minimed Comlink, Hardware Model 7304 & Software Model 7311MRZ · Traditional | 08/06/2002SE |
| K010377 | Mimimed Sil-Serter Infusion Set Insertion System, Model 385KZH · Traditional | 04/05/2001SE |
| K001829 | Minimed Paradigm Insulin Pump, Model 511FRN · Traditional | 08/18/2000SE |
| K001828 | Paradigm 1.5ML Reservoir, Model 326FRN · Traditional | 08/18/2000SE |
| K001827 | Paradigm Sof-Set Micro QR, Models 324 and 325FPA · Traditional | 08/18/2000SE |
Questions and answers
When was Paradigm Sof-Set Ultimate QR, Models 317 and 318 cleared by the FDA?
Paradigm Sof-Set Ultimate QR, Models 317 and 318 (K001832) received a 510(k) decision of Substantially Equivalent on August 18, 2000, 63 days after the submission was received.
What is the product code of K001832?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.