# K210279: Enbio S

- Pathway: 510(k) (Traditional)
- Applicant: Enbio Group AG
- Decided: Oct 29, 2021 after 270 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 K190062 (2019). 1 ancestor in all.
3 later devices descend from it; 2 cite 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)
- K190062: STATCLAVE G4 Chamber Autoclave, Scican, Ltd. (2019) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Enbio S is an 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 Enbio S 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 name, load description, sterilization temperature, exposure time, drying time and maximum load.

Source page: https://510kreport.com/device/K210279
Methodology: https://510kreport.com/methodology