# K962903: Prestige Medical Series 2100 Clinical Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Prestige Medical Corp.
- Decided: Mar 3, 1998 after 586 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: 1 generation back to K900432 (1990). 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)
- K910789: Kavoklave Steam Autoclave, Kavo America (1991) Summary page 1.
- K900432: Model #M8 Electronic Sterilizer, Midmark Corp. (1990) Summary page 1.

## Most influential descendants
- K063681: Tecno-Gaz Andromeda Vacuum CS Autoclave (2007), 0 descendants of its own

## Indications for use
The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121" Celsius saturated steam process for 18 minutes

Source page: https://510kreport.com/device/K962903
Methodology: https://510kreport.com/methodology