# K180272: Saniclave 250

- Pathway: 510(k) (Traditional)
- Applicant: Revolutionary Science
- Decided: Jul 26, 2018 after 176 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 K833837 (1984). 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)
- K112811: Saniclave 200, Alternative Pioneering Research and Development (2012) Summary page 4.

## Indications for use
The Revolutionary Science Saniclave 250 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped and unwrapped heat and moisture stable solid instruments. mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes. The Saniclave 250 has 3 factory-programmed cycles: Cycle Sterilization Temperature | Sterilize Time | Dry Time | Recommended Load Gravity, 121°C, small load, wrapped* | 30 minutes | 30 minutes | 1 tray, wrapped* instruments, maximum weight 4.5 Ibs; Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars Gravity, 121°C, small load, unwrapped* | 30 minutes | N/A | 1 tray, unwrapped* instruments, maximum weight 4.5 Ibs; Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars Gravity, 121°C, large load, unwrapped* | 30 minutes | N/A | 3 trays, unwrapped* loaded evenly, maximum weight 8.0 Ibs; Heat and moisture stable solid instruments, lumened devices and trocars only *4 wrapped load is wrapped or pouched in autoclave packaging that is FDA cleared for 30 min at 121°C. An unwrapped load is not wrapped or pouched and is intended for immediate use.

Source page: https://510kreport.com/device/K180272
Methodology: https://510kreport.com/methodology