F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock
FDA 510(k) K042129 · Cedic S.R.L.
510(k) numberK042129
Submission
- Device name
- F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock
- Applicant
- Cedic S.R.L.
Peschiera Borromeo, IT - Received
- August 6, 2004
- Decision date
- January 27, 2005
- 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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| 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.
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|---|---|---|
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding TubesPIF · Traditional | 04/25/2019SE |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus AdapterPIF · Traditional | 04/09/2019SE |
| K162254 | Cedic Enteral ENFit Transition ConnectorsPIO · Traditional | 05/04/2017SE |
| K150010 | Cedic Oral/Luer Enteral ENFit Transition Connector for Medication PortPIO · Traditional | 04/02/2015SE |
| K140581 | Cedic Enteral Distal End Enfit Transition Connector, Cedic Enteral Enfit Transition…PIO · Traditional | 10/17/2014SE |
| K072652 | Enteral Feeding Spike AdapterKNT · Traditional | 01/18/2008SE |
Questions and answers
When was F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock cleared by the FDA?
F00010 - IV Gravity Setwith Male Luer Slip; F00027 - IV Gravity Set with Male Luer Lock (K042129) received a 510(k) decision of Substantially Equivalent on January 27, 2005, 174 days after the submission was received.
What is the product code of K042129?
The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.