# K052532: Imax 9.5 Sterilizers

- Pathway: 510(k) (Traditional)
- Applicant: Dental X Srl
- Decided: Sep 5, 2006 after 355 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 K936181 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945117: DELTA, Pelton & Crane Co. (1997) Summary page 1.
- K023348: Midmark M9 Ultraclave Steam Sterilizer, Midmark Corp. (2003) Summary page 1.

## Indications for use
The iMax 9.5 DS Sterilizer is a gravity table-top steam sterilizer intended for heat and moisture resistant medical and dental (including complex lumened devices such as dental handpieces) instruments and cloth packs for sterilization in healthcare facilities. Three pre-programmed sterilization cycles are provided with the iMax 9.5 DS Sterilizer (see table below). Cycle | Temperature (°C) | Pressure (bar) | Exposure Time (min.) | Drying Time (min.) | Maximum Load (kg) Unwrapped instruments* | 134 | 2.14 - 2.21 | 4 | 6 | 4.0 Wrapped instruments | 134 | 2.14 - 2.21 | 20 | 20 | 4.0 Packs | 121 | 1.10 - 1.17 | 30 | 20 | 1.5 * Not indicated for the processing of complex instruments (ie. containing lumens, hinges, mated surfaces, etc.) **Dental handpieces can be processed in the Wrapped instruments cycle only The sterilizer is not intended to sterilize patient-contacting liquids.

Source page: https://510kreport.com/device/K052532
Methodology: https://510kreport.com/methodology