RMS Subcutaneous Needle Set
FDA 510(k) K102512 · Repro-Med Systems, Inc.
510(k) numberK102512
Submission
- Device name
- RMS Subcutaneous Needle Set
- Applicant
- Repro-Med Systems, Inc.
New York, NY, US - Received
- September 1, 2010
- Decision date
- May 20, 2011
- 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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| K254123 | Ecomed Disposable Administration SetsFPA · Abbreviated | Ecomed Solutions, LLC | 09/11/2026SE |
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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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| 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 |
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| K243392 | Infusomat® Space Volumetric Infusion Pump Administration SetsFPA · Traditional | B.Braun Medical, Inc. | 07/24/2025SE |
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|---|---|---|
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| K894299 | Repro-Med Emergency Airway Vacuum SystemBSY · Traditional | 09/22/1989SE |
| K892529 | Repro-Med Neonate Aspiration SystemBSY · Traditional | 06/12/1989SE |
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Questions and answers
When was RMS Subcutaneous Needle Set cleared by the FDA?
RMS Subcutaneous Needle Set (K102512) received a 510(k) decision of Substantially Equivalent on May 20, 2011, 261 days after the submission was received.
What is the product code of K102512?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.