No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.
FDA 510(k) K851981 · Superior Plastic Products Corp.
510(k) numberK851981
Submission
- Device name
- No. 5300-3 1/2 French Umbilical Vessel Cath. Etc.
- Applicant
- Superior Plastic Products Corp.
Cumberland, RI, US - Received
- May 7, 1985
- Decision date
- June 18, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K843975 | 9 French 42LONG Polyurethane Graduated Enteric FeKNT · Traditional | 11/20/1984SE |
| K841945 | Enteral Feeding BottleKNT · Traditional | 07/26/1984SE |
| K841630 | Enteral Nutrition PumpFRN · Traditional | 06/07/1984SE |
| K841480 | Infection Control ValveBSY · Traditional | 04/25/1984SE |
| K840324 | Silicone Sump Drain 20 & 40 FrenchJCY · Traditional | 04/25/1984SE |
| K840323 | Silicone Suction & Irrigation DrainGBX · Traditional | 04/25/1984SE |
| K833687 | Dispos. Enteric Feeding Tubes W/Safe-TKNT · Traditional | 03/02/1984SE |
| K833947 | Superior Enternal Feeding SystemKNT · Traditional | 02/04/1984SE |
| K820460 | 3.5 & 5.5 Oz. Sodium Chloride SolutionJOL · Traditional | 03/08/1982SE |
| K812312 | Sterile Water 4OZ.JOL · Traditional | 11/13/1981SE |
Questions and answers
When was No. 5300-3 1/2 French Umbilical Vessel Cath. Etc. cleared by the FDA?
No. 5300-3 1/2 French Umbilical Vessel Cath. Etc. (K851981) received a 510(k) decision of Substantially Equivalent on June 18, 1985, 42 days after the submission was received.
What is the product code of K851981?
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.