I-Port Advance Injection Port
FDA 510(k) K120337 · Unomedical A/S
510(k) numberK120337
Submission
- Device name
- I-Port Advance Injection Port
- Applicant
- Unomedical A/S
Osted, DK - Received
- February 3, 2012
- Decision date
- February 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K210544 | Medtronic Extended infusion setFPA · Traditional | 07/16/2021SE |
| K192647 | neria guard Infusion SetFPA · Traditional | 12/13/2019SE |
| K173879 | MiniMed Mio Advance infusion setFPA · Traditional | 03/05/2018SE |
| K162812 | Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…FPA · Traditional | 11/01/2017SE |
| K160648 | MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®FPA · Traditional | 08/10/2016SE |
| K132142 | Neria Soft 90 Infusion SetFPA · Traditional | 10/08/2013SE |
| K070430 | Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion SetsFPA · Traditional | 04/04/2007SE |
| K061374 | Intuition Infusion SetsFPA · Traditional | 07/31/2006SE |
| K051264 | Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsFPA · Traditional | 09/01/2005SE |
| K041545 | Contact DetachFPA · Special | 06/30/2004SE |
Questions and answers
When was I-Port Advance Injection Port cleared by the FDA?
I-Port Advance Injection Port (K120337) received a 510(k) decision of Substantially Equivalent on February 16, 2012, 13 days after the submission was received.
What is the product code of K120337?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.