SteriTite Container System with MediTray Products
FDA 510(k) K212711 · Case Medical, Inc.
510(k) numberK212711
Submission
- Device name
- SteriTite Container System with MediTray Products
- Applicant
- Case Medical, Inc.
Bloomfield, NJ, US - Received
- August 26, 2021
- Decision date
- April 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6850
- Specialty
- General Hospital
Other 510(k)s with product code KCT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253988 | LiteSet TraysKCT · Traditional | Nobel Biocare AB | 09/08/2026SE |
| K261935 | Surgical and Prosthetic TraysKCT · Traditional | Dentsply Sirona, Inc. | 09/04/2026SE |
| K253187 | SteriBest® Sterilization Tray SystemKCT · Traditional | Mastel Surgical | 06/18/2026SE |
| K260726 | Straumann® ProClean Cassette (041.800 ; 041.801)KCT · Traditional | Institut Straumann AG | 06/03/2026SE |
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | Case Medical, Inc. | 06/03/2026SE |
| K253791 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System LidKCT · Traditional | DePuy Mitek, Inc. | 02/26/2026SE |
| K251614 | Stainless Steel Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 02/06/2026SE |
| K251756 | Sterilization TraysKCT · Traditional | Paragon Implant Mfg., LLC | 11/14/2025SE |
| K251300 | Plastic Surgical KitsKCT · Traditional | Dentsply Sirona, Inc. | 07/22/2025SE |
| K243425 | Guided DAS Surgical KitKCT · Traditional | Talladium España, SL | 07/22/2025SE |
More from Talladium España, SL
| 510(k) | Device | Decision |
|---|---|---|
| K252854 | SteriTite Container System with MediTray ProductsKCT · Traditional | 06/03/2026SE |
| K240898 | SteriTite rigid reusable sterilization container with MediTray ProductsKCT · Traditional | 07/31/2024SE |
| K221492 | SteriTite Container System with MediTray PartsKCT · Traditional | 10/07/2022SE |
| K173259 | Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray…KCT · Traditional | 06/13/2018SE |
| K161415 | SteriTite Containers System & MediTray ProductsFRG · Traditional | 02/10/2017SE |
| K112904 | Steritec Containers System & Meditray ProductsFRG · Traditional | 01/24/2012SE |
| K110682 | Steritite Container System & Meditray ProductsKCT · Traditional | 07/01/2011SE |
| K090068 | Steritite Universal Container System and Meditray ProductsFRG · Traditional | 02/24/2010SE |
| K080558 | Steritite Container System & Meditray ProductsFRG · Traditional | 12/05/2008SE |
| K022978 | Steritite Container with Flashtite Valve Plate(S) & Meditray ProductsFRG · Traditional | 05/09/2003SE |
Questions and answers
When was SteriTite Container System with MediTray Products cleared by the FDA?
SteriTite Container System with MediTray Products (K212711) received a 510(k) decision of Substantially Equivalent on April 29, 2022, 246 days after the submission was received.
What is the product code of K212711?
The FDA product code is KCT – Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, a Class II (moderate risk) device regulated under 21 CFR 880.6850.