# K072466: Statim 7000 (Without Usb Port), Model 01-702100, Statim 7000 (with Usb Port), Model 01-702101

- Pathway: 510(k) (Traditional)
- Applicant: Scican, Ltd.
- Decided: Dec 19, 2007 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 K915054 (1992). 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)
- K962179: Stat IM 5000 Cassette Autoclave, Scican (1997) Summary page 1.

## Most influential descendants
- K090670: Midmark M3 Ultrafast Automatic Sterilizer (2009), 0 descendants of its own

## Indications for use
The STAT/M 7000 Cassette Autoclave is a pressure pulse steam autoclave designed to process medical and dental instruments to achieve successful sterilization in a clinical setting. It utilizes saturated steam 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) that are commonly found in medical and dental offices, hospitals, clinics, and other facilities. The instruments must be suitable for steam sterilization at 1340 C (273 0 F) or 121 °C (250°F). The STATIM 7000 Cassette Autoclave is not intended nor recommended for the sterilization of liquids, cloths, textiles, biomedical waste and certain rubber and plastic materials specified in the Operator's Manual. The sterilization cycles as to established times, temperatures and indicated uses for the STATIM 7000 Cassette Autoclave are as follows: CYCLE — TEMPERATURE — PURGE PURGES — STERILIZATION TIME — INTENDED USE UNWRAPPED — 134°C (273°F) — 3 — 3.5 mi. — Solid instruments, hinged instruments, dental handpieces, with drying WRAPPED — 134-C (273°F) — 6 — 3.5 min. — Solid, hollow (including dental handpieces) & hinged instruments wrapped in paper/paper or paper/plastic pouches or paper sterilization wrap, with improved drying performance RUBBER & PLASTICS — 1210 C (250 0 F). — 330 — min. — Instruments of rubber & plastic construction (exceptions are listed in the Operator's Manual) with drying

Source page: https://510kreport.com/device/K072466
Methodology: https://510kreport.com/methodology