Isolyser Sharps Management System SMS
FDA 510(k) K943626 · Thantex Specialties, Inc.
510(k) numberK943626
Submission
- Device name
- Isolyser Sharps Management System SMS
- Applicant
- Thantex Specialties, Inc.
Norcross, GA, US - Received
- July 26, 1994
- Decision date
- June 16, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K970547 | Isolyser SDS Sharps ContainerFMI · Traditional | 07/18/1997SE |
| K961083 | Orex Surgeon's VestFYA · Traditional | 08/23/1996SE |
| K942200 | Isolyser Orex Surgeon's Caps, Hoods, Bouffant CapsLYU · Traditional | 08/07/1995SE |
| K945755 | Orex(R) O.R Equipment DrapesKKX · Traditional | 05/25/1995SE |
| K945223 | Orex Isolation GownFYC · Traditional | 04/25/1995SE |
| K944859 | Orex Surgical DrapesKKX · Traditional | 02/28/1995SE |
| K944827 | Orex Surgeon's GownFYA · Traditional | 02/28/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | 01/02/1995SE |
| K942228 | Orex O.R. TowelKKX · Traditional | 12/20/1994SE |
| K940767 | Orex (12X12 X-Ray Detectable)GDY · Traditional | 12/19/1994SE |
Questions and answers
When was Isolyser Sharps Management System SMS cleared by the FDA?
Isolyser Sharps Management System SMS (K943626) received a 510(k) decision of Substantially Equivalent on June 16, 1995, 325 days after the submission was received.
What is the product code of K943626?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.