Sharps Container, Model 039-413
FDA 510(k) K063666 · Biodex Medical Systems, Inc.
510(k) numberK063666
Submission
- Device name
- Sharps Container, Model 039-413
- Applicant
- Biodex Medical Systems, Inc.
Shirley, NY, US - Received
- December 11, 2006
- Decision date
- January 25, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMK – Container, Sharps
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code MMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II)MMK · Traditional | Tianjin Huahong Technology Co., Ltd. | 08/05/2026SE |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…MMK · Traditional | Taizhou Huangyan Guanhong Plastic Steel Products… | 05/22/2026SE |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)MMK · Traditional | Zhejiang Gongdong Medical Technology Co., Ltd. | 12/22/2025SE |
| K252637 | Community Containers (Flap and Daisy)MMK · Traditional | Keter Canada, Inc. | 10/14/2025SE |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)MMK · Traditional | Pureway Compliance, Inc. | 10/14/2025SE |
| K231484 | PureWay 1.4 Quart Sharps CollectorMMK · Traditional | Pureway Compliance, Inc. | 09/14/2023SE |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/16/2023SE |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…MMK · Traditional | Ningbo Maxcon Medical Technology Co., Ltd. | 06/01/2023SE |
| K213274 | Qlicksmart BladeFlask UNIVERSALMMK · Abbreviated | Qlicksmart Pty , Ltd. | 06/22/2022SE |
| K211890 | Promisemed Sharps containerMMK · Traditional | Promisemed Hangzhou Meditech Co., Ltd. | 11/17/2021SE |
More from Promisemed Hangzhou Meditech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K090296 | Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336KPT · Traditional | 02/19/2009SE |
| K951770 | Biodex System 3 Model S3S-AP and Model S3D-3APIKK · Traditional | 11/16/1995SE |
| K950981 | Ultra-Pro Ultrasound Scanning Table Model #056-650IXR · Traditional | 04/03/1995SE |
| K942694 | Stability System (110V) Model 945-300; Stability System (220V) Model #945-302KHX · Traditional | 03/10/1995SE |
| K940301 | Compex 2IPF · Traditional | 12/28/1994SN |
| K935520 | Upper Body Cycles (110 VOLT)/(220 Volt)BXB · Traditional | 09/16/1994SE |
| K935216 | Semi-Recumbent CyclesBXB · Traditional | 09/16/1994SE |
| K935061 | Lower Body CyclesBXB · Traditional | 09/16/1994SE |
Questions and answers
When was Sharps Container, Model 039-413 cleared by the FDA?
Sharps Container, Model 039-413 (K063666) received a 510(k) decision of Substantially Equivalent on January 25, 2007, 45 days after the submission was received.
What is the product code of K063666?
The FDA product code is MMK – Container, Sharps, a Class II (moderate risk) device regulated under 21 CFR 880.5570.