# K021064: Quantim 16 Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Scican
- Decided: Aug 8, 2002 after 128 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 K936181 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990189: Modification of: Midmark M-11 Ultraclave Steam Sterilizer, Midmark Corp. (1999)

## Indications for use
The QUANTlM 16 tabletop autoclave is a gravity steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated stearn at high pressures in order to attain an effective kill of infectious bio-organisms and prevent cross infection. The unit is intended to sterilize heat and moisture stable medical and dental instruments (including dental handpieces) which are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 132°C (270°F). Two additional cycles are also specified for (i) the sterilimtion of textiles and wrapped surgical packs and (ii) liquid loads contained in open top glass flasks. Hovever, the QUANTIM 16 Table-top Autoclave is not intended nor recommended for sterilization of liquids intended for direct patient contact. The sterilization cycles as to established time, temperatures, load configurations, drying time and indicated uses for the QUANTM 16 Table-top Autoclave are as follows: CYCLE | STERILIZATION TEMPERATURE | MAXMUM LOAD | STERILIZATION TIME | DRYING TIME | INTENDED USE Unwrapped | 133°C (270°F) | 2k-g (4.41bs) | 3 min. | 30 min. | Flash cycle for solid and hinged instruments, dental handpieces Wrapped | 132°C (270°F) | lkg (2.21bs) | 15 min. | 30 min. | Solid and hinged instruments, dental handpieces Packs | 121”~ (250°F) | Ikg (2.21bs) | 30 rnin. | 30 rnin. | Textiles and wrapped surEical~packs Liquids | | | 30 rnin. | N/A (no drying phase) | Liquids suitable for sterilization in open top flasks (not intended for

Source page: https://510kreport.com/device/K021064
Methodology: https://510kreport.com/methodology