Medcomp Power Injectable Safety Huber Needle
FDA 510(k) K132880 · Medical Components, Inc.
510(k) numberK132880
Submission
- Device name
- Medcomp Power Injectable Safety Huber Needle
- Applicant
- Medical Components, Inc.
Harleysville, PA, US - Received
- September 13, 2013
- Decision date
- January 8, 2014
- 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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| K261530 | iiSure Infusion SetFPA · Special | Deka Research and Development | 06/03/2026SE |
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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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| K130687 | 2F & 3F Vascu-Sheath Tearaway IntroducerDYB · Traditional | 08/15/2013SE |
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| K124046 | Valved Tearaway Introducer Generation IIDYB · Traditional | 06/03/2013SE |
| K123617 | 3F Pro-PiccLJS · Traditional | 05/15/2013SE |
| K122423 | Vasu-PiccLJS · Traditional | 12/12/2012SE |
| K121848 | Split Cath III 24CM Split Cath III 24CM Split Cath III 32CM Cath III 36CM Split Cath III…MSD · Special | 09/21/2012SESK |
| K120281 | Dignity Power Injectable Titanium PortLJT · Traditional | 09/17/2012SE |
Questions and answers
When was Medcomp Power Injectable Safety Huber Needle cleared by the FDA?
Medcomp Power Injectable Safety Huber Needle (K132880) received a 510(k) decision of Substantially Equivalent on January 8, 2014, 117 days after the submission was received.
What is the product code of K132880?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.