# K122978: Saniclave 102, Model RS-SC-102

- Pathway: 510(k) (Traditional)
- Applicant: Alternative Pioneering Research and Development
- Decided: May 23, 2013 after 239 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 1.

## Indications for use
The Revolutionary Science Saniclave 102 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 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. Unwrapped instruments that were sterilized should be used immediately after sterilization is completed (immediate use sterilization). The chamber must be manually drained and wiped dry after each cycle.

Source page: https://510kreport.com/device/K122978
Methodology: https://510kreport.com/methodology