# K090670: Midmark M3 Ultrafast Automatic Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Jul 7, 2009 after 116 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K915054 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915054: Statim Cassett Autoclave, Modification, Scican (1992) Summary page 1.
- K072466: Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101, Scican, Ltd. (2007) Summary page 1.

## Indications for use
The Midmark M3 UltraFast™ Automatic Sterilizer can be used in medical, dental, and veterinary 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. Refer to Standard Cycle Parameters, in Table-I, on the following page, for detailed information:

Source page: https://510kreport.com/device/K090670
Methodology: https://510kreport.com/methodology