CPR Eye Tray
FDA 510(k) K960242 · Custom Pack Reliability
510(k) numberK960242
Submission
- Device name
- CPR Eye Tray
- Applicant
- Custom Pack Reliability
Orlando, FL, US - Received
- January 16, 1996
- Decision date
- March 12, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
Other 510(k)s with product code KKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial IIKKX · Traditional | Avery Dennison Medical , Ltd. | 10/25/2023SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 3M Company | 05/18/2023SE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobialKKX · Traditional | Avery Dennison Belgie Bvba | 07/30/2021SE |
| K200238 | ControlRad Sterile CoverKKX · Traditional | Controlrad, Inc. | 04/26/2020SE |
| K163556 | MediClear PreOpKKX · Traditional | Covalontechnologies, Inc. | 09/14/2017SE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXXKKX · Traditional | Foshan Nanhai Plus Medical Co, Ltd. | 06/24/2015SE |
| K141324 | Hongyu Disposable Surgical DrapesKKX · Traditional | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | 04/14/2015SE |
| K140195 | Surgical DrapeKKX · Traditional | Griffith-Lucas, LLC | 09/10/2014SE |
| K140330 | 3M Steri-Drape Fabric Surgical DrapesKKX · Traditional | 3M Healthcare | 08/18/2014SE |
| K141438 | Whitney Medical Solutions EshieldKKX · Traditional | Whitney Medical Solutions | 08/14/2014SE |
More from Whitney Medical Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K960205 | CPR Tracheotomy Care TrayBTO · Traditional | 08/27/1996SE |
| K960243 | CPR C-Section Delivery PackMLS · Traditional | 05/23/1996SE |
| K960239 | CPR D & C TrayHHK · Traditional | 05/23/1996SE |
| K960216 | CPR Suction Catheter KitJOL · Traditional | 04/15/1996SE |
| K960213 | CPR Total Hip PackFRG · Traditional | 04/12/1996SE |
| K960211 | CPR Total Knee PackFRG · Traditional | 04/12/1996SE |
| K960210 | CPR Ortho Hand PackFRG · Traditional | 04/12/1996SE |
| K960206 | CPR Dressing Change TrayFRG · Traditional | 04/12/1996SE |
| K960209 | CPR Heart PackGAW · Traditional | 04/04/1996SE |
| K960215 | CPR Urethral Catheter TrayFCM · Traditional | 04/01/1996SE |
Questions and answers
When was CPR Eye Tray cleared by the FDA?
CPR Eye Tray (K960242) received a 510(k) decision of Substantially Equivalent on March 12, 1996, 56 days after the submission was received.
What is the product code of K960242?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.