# K260254: Enbio PRO

- Pathway: 510(k) (Traditional)
- Applicant: Enbio Group AG
- Decided: Feb 26, 2026 after 30 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: 3 generations back to K190062 (2019). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213991: Enbio S, Enbio Group AG (2022) Summary page 5.

## Indications for use
The Enbio PRO 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 PRO has not been designed to sterilize liquid loads, biomedical 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. Program Name | Load Description | Sterilization Temperature | Sterilization Time | Drying Time | Maximum Load 134°C | solid objects, small porous objects, simple objects recessed, narrow-clearance items, dental handpieces, and textiles; wrapped and unwrapped | 134˚C (273˚F) | 4 minutes | 4 minutes | 1.6 Kg/3.52 lbs 121°C | solid objects, small porous objects, simple objects recessed, narrow-clearance items, dental handpieces, textiles, and plastics; wrapped and unwrapped | 121°C (250˚F) | 30 minutes | 5:30 minutes | 1.6 Kg/3.52 lbs 134°C FAST* | solid objects, non-porous objects, simple instruments (such as scissors, handles, pliers, chisels, probes, etc.), and dental handpieces; unwrapped. *Immediate Use Steam Sterilization cycle | 134˚C (273˚F) | 4 minutes | N/A | 1.6 Kg/3.52 lbs

Source page: https://510kreport.com/device/K260254
Methodology: https://510kreport.com/methodology