# K161848: Family of Steam sterilizers B17 B22 Series

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Feb 23, 2017 after 233 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: 7 generations back to K003470 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151597: Family of Steam Sterilizers B 28 series, Cefla S.C. (2016) Summary page 15.

## Indications for use
B CLASSIC-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B CLASSIC-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B FUTURA-17 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products. B FUTURA-22 is a steam sterilizer that is intended for use by a health care provider (i.e. hospitals, medical and dental practices, clinics, and nursing homes) to sterilize re-usable medical products that are heat and moisture resistant and compatible with the steam sterilization process. The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Source page: https://510kreport.com/device/K161848
Methodology: https://510kreport.com/methodology