Who else makes this device?

Name: M11 Ultraclave
Brand: M11 Ultraclave

General Hospital › MiscellaneousSterilizer, Steam

M11 Ultraclave

"The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items…

Registry build 21.09.26

“The M11 Ultraclave can be used in medical and dental offices, hospitals, clinics,nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable items (including dental handpieces) that are compatible with steam sterilization”

3manufacturers in China registered for this device type

3catalogue numbers in this listing

9510(k) clearances naming this product code

2recalls on this code

Who Else Makes It

Concentrated in Shanghai (1), Guangdong (1), Zhejiang (1).

Chinese manufacturers registered for FDA product code FLE
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

Regulatory record for M11 Ultraclave
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	2018-07-06 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Over the counter	Yes
Label carries	manufacturing date, serial number
Storage	Handling environment atmospheric pressure 49.642 to 106.18 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature -30 to 60 °C; Storage environment atmospheric pressure 49.642 to 106.18 KiloPascal; Storage environment humidity 10 to 90 % RH; Storage environment temperature -30 to 60 °C

Catalogue Numbers

Catalogue numbers for M11 Ultraclave
Catalogue number	Size	Status
M11-020		In distribution
M11-021		In distribution
M11-020R		In distribution

Same Product Code

Other products under the same FDA 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

FDA 510(k) clearances naming this product code
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.

Recalls referencing this product code
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.