510(k) · Cleared
ClearedLife Ultra 25L Tabletop Mono Chamber Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lucas Lifecare · FLE Sterilizer, Steam
Cleared on Dec 30, 2025 as substantially equivalent to K232658 (Tuttnauer U.S.A Co, Ltd., 2023) after a 343-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Dec 30, 2025
- Review
- 343 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K003470 (2001). 17 ancestors in all, the oldest K850264 (1985). No later device cites it as a predicate yet.
- Root · 8 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 7 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 6 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 5 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 4 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 3 generations backK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- 2 generations backK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- 1 generation backK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- This deviceK250168 Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −7 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −6 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −5 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −4 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −3 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| −2 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| −1 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| 0 (this device) | K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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 K252307 Getinge GSS67N Series Steam Sterilizerscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K232658 | T-Top 10 & T-Top T-Top 11Summary page 5…ification Name : Steam Sterilizer Regulatory Class II 3. Legally Marketed Predicate Device Information: (K232658) Trade/ Device Name : T-Top (T-Top 11) Manufacturer Name : Tuttnauer… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 17 ancestors has a recall of any class.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
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?
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements. Validated sterilization cycles of LifeUltra include: Class B cycles • 134 °C…
Read the full statement (151 words)
Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer is intended to be used in medical, dental, surgical, healthcare, and laboratory applications (e.g hospitals, nursing homes, surgical centers, healthcare clinics, or dental offices) to sterilize heat and moisture-stable reusable loads that are solid, hollow, porous, or delicate, in either wrapped or unwrapped arrangements.
Validated sterilization cycles of LifeUltra include:
Class B cycles
• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments, hand pieces, textiles, and porous loads (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate or wrapped/unwrapped loads (max 7 kg).
Class S cycles
• 134 °C (273 °F) for 4 minutes sterilization with 20 minutes drying - wrapped/unwrapped instruments and hand pieces (max 7 kg).
• 121 °C (250 °F) for 20 minutes sterilization with 20 minutes drying - delicate loads (max 7 kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250168 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250168: Life Ultra 25L Tabletop Mono Chamber 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/K250168
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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