# K112811: Saniclave 200

- Pathway: 510(k) (Traditional)
- Applicant: Alternative Pioneering Research and Development
- Decided: Jan 11, 2012 after 106 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 K833837 (1984). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953938: Sterilemax, Barnstead/Thermolyne Corp. (1997) Summary page 1.

## Most influential descendants
- K180272: Saniclave 250 (2018), 0 descendants of its own
- K122978: Saniclave 102, Model RS-SC-102 (2013), 0 descendants of its own

## Indications for use
The Revolutionary Science Saniclave 200 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 and hinged devices (excluding lumened devices and dental hand pieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.

Source page: https://510kreport.com/device/K112811
Methodology: https://510kreport.com/methodology