Tamper Evident Cap with Male Luer Lock
FDA 510(k) K182545 · International Medical Industries, Inc.
510(k) numberK182545
Submission
- Device name
- Tamper Evident Cap with Male Luer Lock
- Applicant
- International Medical Industries, Inc.
Pompano Beach, FL, US - Received
- September 17, 2018
- Decision date
- January 11, 2019
- 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 |
| 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 |
|---|---|---|
| K231095 | Tamper Evident CapFMF · Traditional | 09/04/2024SE |
| K201031 | NRFit® Caps, Male and Female Neuraxial Tip CapsQEH · Traditional | 12/16/2020SE |
| K193192 | Tamper Evident CapFMF · Special | 01/31/2020SE |
| K190305 | Additive CapKPE · Traditional | 04/30/2019SE |
| K173577 | Guarded Luer ConnectorLHI · Traditional | 06/07/2018SE |
| K170672 | Tamper Evident Cap For use with ENFit SyringesPNR · Traditional | 10/06/2017SE |
Questions and answers
When was Tamper Evident Cap with Male Luer Lock cleared by the FDA?
Tamper Evident Cap with Male Luer Lock (K182545) received a 510(k) decision of Substantially Equivalent on January 11, 2019, 116 days after the submission was received.
What is the product code of K182545?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.