Sterile Design-Custom Sterile IV Kit
FDA 510(k) K842351 · Sterile Design, Inc.
510(k) numberK842351
Submission
- Device name
- Sterile Design-Custom Sterile IV Kit
- Applicant
- Sterile Design, Inc.
Oldsmar, FL, US - Received
- June 15, 1984
- Decision date
- October 15, 1984
- 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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|---|---|---|---|
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| 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 |
|---|---|---|
| K934688 | Sterile DesignLRO · Traditional | 03/16/1994SEKD |
| K841960 | Cardio Metrics Invasive Pressure MonitDRS · Traditional | 11/08/1985SE |
| K842356 | Custom Sterile Procedure Kits · Traditional | 03/21/1985SE |
| K841959 | Cardio Metric Custom Perfusion TubingDWE · Traditional | 10/19/1984SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | 10/15/1984SE |
| K834239 | Sdi C-Flex Sterile Light Handle · Traditional | 04/25/1984SE |
| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | 10/02/1979SE |
Questions and answers
When was Sterile Design-Custom Sterile IV Kit cleared by the FDA?
Sterile Design-Custom Sterile IV Kit (K842351) received a 510(k) decision of Substantially Equivalent on October 15, 1984, 122 days after the submission was received.
What is the product code of K842351?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.