Protector (Surgical Instrument)
FDA 510(k) K890314 · Richard-Allan Medical Ind., Inc.
510(k) numberK890314
Submission
- Device name
- Protector (Surgical Instrument)
- Applicant
- Richard-Allan Medical Ind., Inc.
Richland, MI, US - Received
- January 23, 1989
- Decision date
- February 27, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K931879 | Reflex HTRGCJ · Traditional | 03/24/1994SE |
| K924200 | Reflex(R) EscKNF · Traditional | 02/22/1994SE |
| K926297 | Reflex EsiGEI · Traditional | 10/15/1993SE |
| K924761 | Sterile Endoscopic Dispos Trocars W/Safe ShieldGCJ · Traditional | 04/20/1993SE |
| K900566 | Richard-Allan Vessel LoopsKDC · Traditional | 05/03/1990SE |
| K896262 | Titanium Ligating ClipsHBT · Traditional | 01/02/1990SE |
| K873309 | Reflex(Tm) Ca-T Clip ApplierFZP · Traditional | 11/27/1987SE |
| K862404 | Reflex(Tm) Clip ApplierFZP · Traditional | 07/23/1986SE |
| K862223 | Micro Thin* ParaffinKEO · Traditional | 06/17/1986SE |
| K861890 | 100%, 95%, 80% & 70% Dehydrant Custom Blend No. 2PPM · Traditional | 06/03/1986SE |
Questions and answers
When was Protector (Surgical Instrument) cleared by the FDA?
Protector (Surgical Instrument) (K890314) received a 510(k) decision of Substantially Equivalent on February 27, 1989, 35 days after the submission was received.
What is the product code of K890314?
The FDA product code is MMK – Container, Sharps, a Class II (moderate risk) device regulated under 21 CFR 880.5570.