Safepass Sterilization Pouch
FDA 510(k) K973981 · Adroit Medical Systems, Inc.
510(k) numberK973981
Submission
- Device name
- Safepass Sterilization Pouch
- Applicant
- Adroit Medical Systems, Inc.
Loudon, TN, US - Received
- October 20, 1997
- Decision date
- January 29, 1998
- 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 |
|---|---|---|
| K073712 | Soft Air, Model SA 4000 and Mistral Air, Model MA0100DWJ · Traditional | 06/06/2008SE |
| K970197 | HTP-1500 Localized Heat Therapy PumpILO · Traditional | 09/10/1997SE |
| K962983 | Sterile Soft-TempILO · Traditional | 01/10/1997SE |
| K921920 | Soft-TempDWJ · Traditional | 12/11/1992SE |
| K921928 | Soft-CoverFMW · Traditional | 11/06/1992SE |
Questions and answers
When was Safepass Sterilization Pouch cleared by the FDA?
Safepass Sterilization Pouch (K973981) received a 510(k) decision of Substantially Equivalent on January 29, 1998, 101 days after the submission was received.
What is the product code of K973981?
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.