AIR Filter
2 catalogue numbers from MAJ-823, listed by Olympus Medical Systems Corp., Japan, under Accessories, Cleaning, For Endoscope. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
5510(k) clearances naming this product code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | FEB |
| Device type | Accessories, Cleaning, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K201920 |
| Record published | 2023-04-22 |
| Record revised | 2024-07-23 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2024-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAJ-823 | Withdrawn | |
| MAJ-823 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medivators Hookup | Medivators Inc | 333 |
| Evotech™ | Advanced Sterilization Products Services Inc. | 104 |
| Connecting Tube | Olympus Medical Systems Corp. | 47 |
| Accessories, Cleaning, For Endoscope | Steris Corporation | 39 |
| Accessories, Cleaning, For Endoscope | Pentax of America, Inc. | 24 |
| Accessories, Cleaning, For Endoscope | Richard Wolf Gmbh | 16 |
| ASP Aeroflex™ | Advanced Sterilization Products Services Inc. | 10 |
| Scope Buddy Plus Tubing | Medivators Inc | 9 |
| Accessories, Cleaning, For Endoscope | Corporation Steris Canada | 8 |
| Scope Assist Flushing Sink (Safs) | Wassenburg Medical, Inc. | 6 |
| System 83 Plus | Wassenburg Medical, Inc. | 4 |
| Leak Test AIR Tube | Olympus Medical Systems Corp. | 4 |
Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201920 | 2020-09-01 |
| K190969 | 2019-07-09 |
| K120357 | 2012-12-20 |
| K103264 | 2011-02-23 |
| K093106 | 2010-02-12 |
Recalls Naming This Product
16 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 9,757 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 10,141 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 8,994 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 8,936 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 2,143 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | XXX | 2,089 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 373 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 1,929 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 1,259 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 741 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 808 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-03-25 | Class II | Device Design | Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. | 1,829 units | |
| Olympus Corporation of the Americas | 510(k) number | 2026-02-12 | Class II | Reprocessing Controls | The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. | 2,929 units | |
| Aizu Olympus Co., Ltd. | 510(k) number | 2025-10-31 | Class II | Under Investigation by firm | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. | 6578 units | |
| Olympus Corporation of the Americas | 510(k) number | 2023-05-26 | Class II | Labeling Change Control | Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatibl | 1063 units | |
| Olympus Corporation of the Americas | 510(k) number | 2021-12-13 | Class II | Process control | The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instea | 295 units | 2023-12-26 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.