M11 Horizontal Cassette Rack
The M11 horizontal cassette rack holds four large and for small cassettes
3manufacturers in China registered for this device type
1catalogue number
9510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Ningbo Ican Machines Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Midmark Corporation, United States |
|---|---|
| FDA product code | FLE |
| Device type | Sterilizer, Steam |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6880 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K990189 |
| Record published | 2016-09-23 |
| Record revised | 2018-11-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9A215001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Amsco | Steris Mexico, S. de R.L. de C.V. | 434 |
| Getinge 500 Series | Getinge IC Production Poland sp. z o.o. | 133 |
| Getinge 700 Series | Getinge IC Production Poland sp. z o.o. | 82 |
| Aesculap | Aesculap AG | 67 |
| Getinge 600 Series | Getinge IC Production Poland sp. z o.o. | 61 |
| Sterilizer, Steam | Steris Mexico, S. de R.L. de C.V. | 53 |
| Getinge 800 Series | Getinge IC Production Poland sp. z o.o. | 41 |
| Getinge 400 Series | Getinge IC Production Poland sp. z o.o. | 37 |
| Primus Sterilizer | Primus Sterilizer Company, LLC. | 24 |
| Midmark | Midmark Corporation | 21 |
| Bravo 17V Autoclave | Scican Ltd. | 19 |
| Atlas | Steris Mexico, S. de R.L. de C.V. | 18 |
Showing 12 of 119. All products under Sterilizer, Steam
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233026 | 2024-04-04 |
| K163337 | 2017-08-31 |
| K090670 | 2009-07-07 |
| K023348 | 2003-03-03 |
| K992744 | 2000-01-10 |
| K990189 | 1999-04-19 |
| K936181 | 1994-11-30 |
| K911322 | 1991-08-26 |
| K900432 | 1990-07-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-10-24 | Not classified | Employee error | During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning. | 30,255 units | 2014-06-20 |
| 2003-03-05 | Not classified | Other | The pressure relief valve may fail to open properly. | 35 | 2004-01-20 |
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.