Paradigm Silhouette, Models MMT-377, 378, 379, 380
FDA 510(k) K002138 · Maersk Medical A/S
510(k) numberK002138
Submission
- Device name
- Paradigm Silhouette, Models MMT-377, 378, 379, 380
- Applicant
- Maersk Medical A/S
Sylmar, CA, US - Received
- July 17, 2000
- Decision date
- August 29, 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
Other 510(k)s with product code FPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
| 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 |
|---|---|---|
| K011071 | Paradigm Quick-Set Infusion SetFPA · Traditional | 06/07/2001SE |
| K990115 | Disposable ECG Monitoring Electrodes, Models, 4420, 4440DRX · Traditional | 12/06/1999SE |
| K990113 | Disposable ECG Monitoring Electrodes, Models 4500,4530, 4533, 4539, 4540, and 4560DRX · Traditional | 12/06/1999SE |
| K990112 | Disposable ECG Monitoring Electrodes, Models 4060, 4610DRX · Traditional | 12/06/1999SE |
| K990111 | Disposable ECG Monitoring Electrodes, Models 4520, 4535, 4570DRX · Traditional | 12/06/1999SE |
| K990110 | Disposable ECG Monitoring Electrodes, Model 4110, 4140DRX · Traditional | 12/06/1999SE |
| K991759 | Maersk Medical Contour Infusion SetFPA · Traditional | 06/25/1999SE |
| K973364 | 4L Drainage Bag, 4L Bag for Peritoneal Dialysis, 4L Urinary Drainage BagKNX · Traditional | 03/17/1998SE |
Questions and answers
When was Paradigm Silhouette, Models MMT-377, 378, 379, 380 cleared by the FDA?
Paradigm Silhouette, Models MMT-377, 378, 379, 380 (K002138) received a 510(k) decision of Substantially Equivalent on August 29, 2000, 43 days after the submission was received.
What is the product code of K002138?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.