Procedure Ready Trays
FDA 510(k) K884577 · Professional Medical Services
510(k) numberK884577
Submission
- Device name
- Procedure Ready Trays
- Applicant
- Professional Medical Services
North Salt Lake, UT, US - Received
- November 1, 1988
- Decision date
- August 1, 1989
- Decision
- Unknown (SESD)
- 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 |
|---|---|---|
| K913094 | Disposable Slide Valve ManifoldDQO · Traditional | 01/27/1992SE |
| K910378 | Pressure Monitoring Extension LineDQO · Traditional | 04/22/1991SE |
| K904508 | Condor Analog Inflation SyringeMAV · Traditional | 04/02/1991SE |
| K904954 | Condor Digital Inflation SyringeMAV · Traditional | 01/16/1991SE |
| K902606 | Radiopaque RulerKPR · Traditional | 09/27/1990SE |
| K890471 | PMS Angio DrapeKKX · Traditional | 02/27/1989SE |
| K884497 | Control SyringeFMF · Traditional | 12/12/1988SE |
| K872448 | Blood Containment PackLRO · Traditional | 11/17/1987SE |
| K864555 | 3 Ring AttachmentFMF · Traditional | 12/01/1986SE |
| K854941 | PMS Percutaneous Puncture NeedleDYB · Traditional | 04/16/1986SE |
Questions and answers
When was Procedure Ready Trays cleared by the FDA?
Procedure Ready Trays (K884577) received a 510(k) decision of Unknown on August 1, 1989, 273 days after the submission was received.
What is the product code of K884577?
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.