# K151597: Family of Steam Sterilizers B 28 series

- Pathway: 510(k) (Traditional)
- Applicant: Cefla S.C.
- Decided: Mar 4, 2016 after 266 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: 6 generations back to K003470 (2001). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU, M.O. Com S.R.L. (2006) Summary page 8.
- K143311: Pre-vacuum Tabletop Autoclave, Tuttnauer U.S.A Co, Ltd. (2015) Summary page 8.

## Most influential descendants
- K161848: Family of Steam sterilizers B17 B22 Series (2017), 0 descendants of its own

## Indications for use
The Family of steam Sterilizers B 28 series B CLASSIC-28 and B FUTURA-28 models are table top steam sterilizers to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process. The Family of Steam Sterilizers B 28 series is validated for sterilization of fabric packs/textiles for sterilization programs C1 and C2. The Family of Steam Sterilizers B 28 series is validated for sterilization up to 9 dental handpieces for sterilization programs C1 and C2. The Family of Steam Sterilizers B 28 series is validated for sterilization up to 6 lumen devices (specifications in the table below) The device shall not be used for the sterilization of fluids, liquids or pharmaceutical products.

Source page: https://510kreport.com/device/K151597
Methodology: https://510kreport.com/methodology