Vanishpoint I.V. Catheter
FDA 510(k) K081420 · Retractable Technologies, Inc.
510(k) numberK081420
Submission
- Device name
- Vanishpoint I.V. Catheter
- Applicant
- Retractable Technologies, Inc.
Little Elm, TX, US - Received
- May 20, 2008
- Decision date
- November 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K202325 | EasyPoint Blood Collection PlusJKA · Traditional | 04/09/2021SE |
| K133635 | Easypoint NeedleFMI · Traditional | 06/17/2014SE |
| K122355 | Vanishpoint Blood Collection SetJKA · Traditional | 08/23/2013SE |
| K112512 | Vanishpoint Blood Collection SetFPA · Traditional | 10/20/2011SE |
| K101708 | Patient Safe Luer CapFMF · Traditional | 02/24/2011SE |
| K072654 | Patient Safe SyringeFMF · Traditional | 12/14/2007SE |
| K051355 | Vanishpoint I.V. CatheterFOZ · Traditional | 09/23/2005SE |
| K980069 | Vanishpoint SyringeMEG · Traditional | 02/12/1998SE |
| K973301 | Anti-Stick Syringe with Integral Hypodermic Needle/Vanishpoint SyringeMEG · Traditional | 11/07/1997SE |
| K971763 | Blood Collection Tube Holder Vanishpoint Tube Holder/Small Tube AdapterFMI · Traditional | 08/26/1997SE |
Questions and answers
When was Vanishpoint I.V. Catheter cleared by the FDA?
Vanishpoint I.V. Catheter (K081420) received a 510(k) decision of Substantially Equivalent on November 7, 2008, 171 days after the submission was received.
What is the product code of K081420?
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.