Sterile Field Saline and Heparin Lock Flush Syringes
FDA 510(k) K053120 · Excelsior Medical Corp.
510(k) numberK053120
Submission
- Device name
- Sterile Field Saline and Heparin Lock Flush Syringes
- Applicant
- Excelsior Medical Corp.
Neptune, NJ, US - Received
- November 7, 2005
- Decision date
- December 9, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K142620 | 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride…NGT · Traditional | 12/12/2014SE |
| K133446 | Heparin Lock / Flush SyringesNZW · Traditional | 11/14/2014SE |
| K130975 | Swabcap and SwabflushQBP · Traditional | 12/24/2013SE |
| K101270 | Swabflsuh (3ML, 5ML, 10ML) Model 10331, 10351, 10311NGT · Traditional | 02/10/2011SE |
| K083508 | SwabcapQBP · Traditional | 04/28/2009SE |
| K082837 | Sterile Field Saline Pre-Filled Syringe(S)NGT · Special | 12/18/2008SE |
| K061497 | Syrex Heparin Lock Flush Syringe, 1 Unit/Ml & 2 Units/MlNZW · Traditional | 02/23/2007SE |
| K023740 | Syrex Pre-Filled SyringeNZW · Traditional | 05/13/2003SE |
| K962938 | Excelsior Disposable Syringe W/Normal Saline (.9% Sodium Chloride)FOZ · Traditional | 10/25/1996SE |
| K942349 | Microbore Extension SetFPA · Traditional | 02/08/1995SE |
Questions and answers
When was Sterile Field Saline and Heparin Lock Flush Syringes cleared by the FDA?
Sterile Field Saline and Heparin Lock Flush Syringes (K053120) received a 510(k) decision of Substantially Equivalent on December 9, 2005, 32 days after the submission was received.
What is the product code of K053120?
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.