Key Med Leeds Endoscope Disinfector
FDA 510(k) K820152 · Keymed, Inc.
510(k) numberK820152
Submission
- Device name
- Key Med Leeds Endoscope Disinfector
- Applicant
- Keymed, Inc.
Mchenry, IL, US - Received
- January 19, 1982
- Decision date
- January 29, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/DisinfectorFEB · Traditional | Wassenburg Medical, Inc. | 12/19/2024SE |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
| K201920 | Endoscope Reprocessor OER-EliteFEB · Special | Olympus Medical Systems Corp. | 09/01/2020SE |
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | Advanced Sterilization Products (Asp) | 04/23/2019SE |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
More from Medivators, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
Questions and answers
When was Key Med Leeds Endoscope Disinfector cleared by the FDA?
Key Med Leeds Endoscope Disinfector (K820152) received a 510(k) decision of Substantially Equivalent on January 29, 1982, 10 days after the submission was received.
What is the product code of K820152?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.