# K190062: STATCLAVE G4 Chamber Autoclave

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: Jul 26, 2019 after 192 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K210279: Enbio S (2021), 3 descendants of its own
- K213991: Enbio S (2022), 1 descendant of its own
- K260254: Enbio PRO (2026), 0 descendants of its own
- K250164: Cassette Autoclave (ACA5) (2025), 0 descendants of its own

## Recalls of this device
- Jun 22, 2023 · Class II · Z-2285-2023: The STATCLAVE G4 is a dynamic air removal (prevacuum) tabletop steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable f

## Indications for use
The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be sterilized by steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave. Please refer to the table below for program description, cycle times, temperature and dry times.

Source page: https://510kreport.com/device/K190062
Methodology: https://510kreport.com/methodology