510(k) · Cleared
ClearedW & H Lisa Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Dec, Inc. · FLE Sterilizer, Steam
Cleared on Feb 7, 2003 after a 165-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Feb 7, 2003
- Review
- 165 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK022816 W & H Lisa Steam SterilizerA-Dec, Inc. · 2003
- Descendant · cites it directly · 8 of its ownK050263 Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006
- Descendant · 2 generations on · 6 of its ownK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · 3 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK151597 Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K050263Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L. · 2006 · cites it directly8descendants
- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · 2 generations on6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 3 generations on2descendants
- K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023 · 4 generations on1descendant
- K151597Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022816 | W & H Lisa Steam Sterilizer | A-Dec, Inc. | 2003 | — |
| +1 | K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | M.O. Com S.R.L. | 2006 | — |
| +2 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| +3 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| +4 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| +2 | K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050263 | Millennium Series, Including Millennium B, B+, B2 and BU | 2006 | 8 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K050263 (M.O. Com S.R.L., 2006) has gone furthest, with 8 descendants of its own.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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…
Read the full statement (170 words)
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
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K022816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022816: W & H Lisa Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022816
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026