# K022816: W & H Lisa Steam Sterilizer

- Pathway: 510(k) (Abbreviated)
- Applicant: A-Dec, Inc.
- Decided: Feb 7, 2003 after 165 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 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
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU (2006), 8 descendants of its own
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own
- K151597: Family of Steam Sterilizers B 28 series (2016), 1 descendant of its own

## Indications for use
The W&H Lisa Water Steam Sterilizer is designed for pressurized steam sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous and hollow loads. It has the following automated program cycles: Two Sterilization Cycles (summaries): B Standard 273 Cycle | B Standard 250 Cycle Max Temperature 273 °F 250 °F Duration of sterilization 4 min 30 min Pressure 31.5 psi 17 psi Duration of drying 15 min 20 min Total cycle time empty 30 min 65 min Total cycle time full load 40 min 75 min Uses: Full solid load Yes Yes Full porous textile load Yes Yes Small porous items Yes Yes Dental Handpieces Yes Yes Unwrapped material Yes Yes Single/double wrapped 4.5 lbs max. wrapped 4.5 lbs max. wrapped Liquids No No Two Test Cycles (summaries): Bowie & Dick Vacuum Max Temperature 275.9 °F None Duration of sterilization 3 min 20 sec None Max Pressure 31.5 psi -12.3 psi Duration of drying 4 min None Test period N/A 10 min

Source page: https://510kreport.com/device/K022816
Methodology: https://510kreport.com/methodology