Safedweel Dressing Change Tray
FDA 510(k) K950438 · Becton Dickinson Vascular Access, Inc.
510(k) numberK950438
Submission
- Device name
- Safedweel Dressing Change Tray
- Applicant
- Becton Dickinson Vascular Access, Inc.
Sandy, UT, US - Received
- February 2, 1995
- Decision date
- March 15, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRG – Wrap, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code FRG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261897 | HALYARD* ARMOR-FLEX* Sterilization Wrap with ASSURE-DRY* Technology; HALYARD*…FRG · Traditional | O&M Halyard, Inc. | 07/02/2026SE |
| K252823 | Dukal Crepe Paper Sterilization WrapFRG · Traditional | Dukal, LLC | 05/28/2026SE |
| K253454 | HALYARD* ONE-STEP* Sterilization Wrap; HALYARD* QUICK CHECK* Sterilization Wrap…FRG · Traditional | O&M Halyard, Inc. | 05/18/2026SE |
| K251347 | Sterilization Pouch/RollFRG · Traditional | Sterivic Medical Co., Ltd. | 01/28/2026SE |
| K251177 | Self-Seal Sterilization Pouch and RollFRG · Traditional | Guangdong Maidi Medical Co., Ltd. | 12/12/2025SE |
| K250306 | Chex-All Sterilization Pouches and TubesFRG · Abbreviated | Propper Manufacturing Co., Inc. | 10/31/2025SE |
| K243179 | Sterilization Pouch and RollFRG · Traditional | Yichang Xinxin Paper Products Co., Ltd. | 06/26/2025SE |
| K250321 | GCI Sterilization WrappersFRG · Traditional | George Courey, Inc. | 06/06/2025SE |
| K243721 | Self Sealing Sterilization PouchesFRG · Traditional | Wellmed Dental Medical Supply Co., Ltd. | 04/25/2025SE |
| K250011 | Turbett Surgical Instrument Pod (TS1500); Turbett Surgical Instrument Pod (TS1200)…FRG · Traditional | Turbett Surgical | 04/04/2025SE |
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| K970259 | E-Z Set Infusion Set/Saf-T E-Z Set Infusion SetFPA · Traditional | 04/08/1997SE |
| K964050 | First Midcath CatheterFOZ · Traditional | 01/06/1997SE |
| K964049 | First Midcath Catheter with Dual LumensFOZ · Traditional | 01/06/1997SE |
| K964048 | First Midcath Catheter KitFOZ · Traditional | 01/06/1997SE |
| K954906 | First Picc Introducer CatheterDYB · Traditional | 04/08/1996SE |
| K952861 | Angiocath & Insyte Autoguard CathetersFOZ · Traditional | 07/31/1995SE |
| K952757 | Angiocath, Novbalon, Angio-Set Intravascular & Angiocath Introduction Drainage CatheterFOZ · Traditional | 07/31/1995SE |
| K952053 | E-Z Set, Saf-T E-Z Set, and Minicath Infusion SetsFPA · Traditional | 05/31/1995SE |
| K950301 | Angiocath(R) Nonvalon(R) and Angio-Set(R) IV CathetersFOZ · Traditional | 04/18/1995SE |
Questions and answers
When was Safedweel Dressing Change Tray cleared by the FDA?
Safedweel Dressing Change Tray (K950438) received a 510(k) decision of Unknown on March 15, 1995, 41 days after the submission was received.
What is the product code of K950438?
The FDA product code is FRG – Wrap, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.6850.