PRO-LITE Sterilization Tray
FDA 510(k) clearance K231501 · decided 2023-08-07
Clearance details
- K-number
- K231501
- Device name
- PRO-LITE Sterilization Tray
- Applicant
- STERIS Corporation
- Decision
- Substantially Equivalent
- Date received
- 2023-05-24
- Decision date
- 2023-08-07
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- KCT
- Device class
- 2
- Regulation number
- 880.6850
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SteriBest® Sterilization Tray System (K253187) | Mastel Surgical | 2026-06-18 |
| Straumann® ProClean™ Cassette (041.800 ; 041.801) (K260726) | Institut Straumann AG | 2026-06-03 |
| SteriTite Container System with MediTray Products (K252854) | Case Medical, Inc. | 2026-06-03 |
| PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid (K253791) | DePuy Mitek, Inc. | 2026-02-26 |
| Stainless Steel Surgical Kits (K251614) | Dentsply Sirona, Inc. | 2026-02-06 |
| Sterilization Trays (K251756) | Paragon Implant Mfg., LLC | 2025-11-14 |
| Plastic Surgical Kits (K251300) | Dentsply Sirona, Inc. | 2025-07-22 |
| Guided DAS Surgical Kit (K243425) | Talladium España, SL | 2025-07-22 |
| PAL Sterilization Case (K243589) | Microaire Surgical Instruments, LLC | 2025-06-20 |
| Aesculap Aicon® Series Container System (K242762) | Aesculap, Inc. | 2025-05-13 |
| ONE TRAY® Sealed Sterilization Container System (K250029) | Innovative Sterilization Technologies | 2025-05-01 |
| Synthes Graphic Case & Tray System (K241927) | Synthes GmbH | 2025-03-28 |
Recalls involving this device
No recalls on record reference this clearance.