# K992744: Midmark M4*9 Easyclave Steam Sterilizer

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Jan 10, 2000 after 147 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: 2 generations back to K936181 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer, Midmark Corp. (1999) Summary page 1.

## Most influential descendants
- K024133: CLS-2000 Unit (2003), 0 descendants of its own

## Indications for use
The M4+9 EasyClave is to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization at 270°F. Refer to Standard Cycle Parameters below for detailed information. Standard Cycle Parameters Cycle Temp/Press/Time Items to be Sterilized (minimums) (Always consult the item manufacturer’s recommendations for sterilization.) Unwrapped 132°C (270°F)/ Instruments and dental handpieces loose on a tray. 186 kPa (27 psi) Open glass or metal canisters. Cassettes. Tubing 3:30 minutes not used in surgical procedures. Items that are compatible with a maximum temperature of 135° C (276° F). The sterility of unwrapped items is compromised on exposure to a non-sterile environment. Wrapped 132°C (270°F)/ Instruments and dental handpieces. Loosely 186 kPa (27 psi) wrapped individual instruments. Multiple layers of 9 minutes instruments separated by fabric. Wrapped trays of loose instruments. Wrapped cassettes. Tubing not used in surgical procedures. Items that are compatible with a maximum temperature of 135°C (276°F).

Source page: https://510kreport.com/device/K992744
Methodology: https://510kreport.com/methodology