Bemis One Quart Phlebotomy Container (Part Number 100)
FDA 510(k) K960525 · Bemis Mfg. Co.
510(k) numberK960525
Submission
- Device name
- Bemis One Quart Phlebotomy Container (Part Number 100)
- Applicant
- Bemis Mfg. Co.
Sheboygan Falls, WI, US - Received
- February 5, 1996
- Decision date
- March 28, 1996
- 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 |
|---|---|---|
| K020921 | No-Pokes Needle Safety DeviceFMI · Traditional | 07/11/2002SE |
| K965248 | Bemis Two Gallon Sharps ContainerFMI · Traditional | 02/14/1997SE |
| K964858 | Bemis Two Gallon Chemotherapy ContainerMMK · Traditional | 02/11/1997SE |
| K953797 | Sharps Disposal ContainersMMK · Traditional | 11/27/1995SE |
| K950340 | Ight and Eleven Gallon Sharps and Chemotherapy ContainersMMK · Traditional | 06/02/1995SE |
| K941665 | Sharps Disposal Container/PhlebotomyMMK · Traditional | 05/23/1994SE |
| K941664 | Sharp Disposal Containers Wall SafeMMK · Traditional | 05/23/1994SE |
| K931664 | Sharps Disposable ContainersMMK · Traditional | 05/23/1994SE |
| K914601 | Suction Connecting TubingGCX · Traditional | 02/07/1992SE |
| K911576 | Chemotherapy ContainerKPE · Traditional | 07/05/1991SE |
Questions and answers
When was Bemis One Quart Phlebotomy Container (Part Number 100) cleared by the FDA?
Bemis One Quart Phlebotomy Container (Part Number 100) (K960525) received a 510(k) decision of Substantially Equivalent on March 28, 1996, 52 days after the submission was received.
What is the product code of K960525?
The FDA product code is MMK – Container, Sharps, a Class II (moderate risk) device regulated under 21 CFR 880.5570.