510(k) · Cleared
ClearedT-Edge 10, T-Edge 11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuttnauer, Ltd. · FLE Sterilizer, Steam
Cleared on Jan 4, 2022 as substantially equivalent to K143311 (Tuttnauer U.S.A Co, Ltd., 2015) and 1 other predicate after a 103-day review. Its family tree reaches back 6 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 4, 2022
- Review
- 103 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K003470 (2001). 15 ancestors in all, the oldest K850264 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 5 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 4 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 3 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 2 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 1 generation backK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- This deviceK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK250168 Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −5 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −4 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −3 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −2 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −1 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| 0 (this device) | 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 | — |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 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? (2)
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 |
|---|---|---|---|
| * | K143311 | Pre-vacuum Tabletop AutoclaveSummary page 7…Regulation Class 510K no. name Number Name Elara 11 FLE 21CFR Steam Class II K143311 880.6880 Sterilizer EZ11Plus FLE 21CFR Steam Cla… | 2015 |
| * | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesSummary page 7…Steam Class II K143311 880.6880 Sterilizer EZ11Plus FLE 21CFR Steam Class II K111736 880.6880 Sterilizer : Page 2 of 18 === P… | 2011 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K232658 | T-Top 10 & T-Top T-Top 11 | 2023 | 1 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K232658 (Tuttnauer U.S.A Co, Ltd., 2023) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K143311.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
The T-Edge 10 & T-Edge 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices).
The T-Edge 10 & T-Edge 11 are validated for use in:
• Sterilizing fabric packs / textiles
• Sterilizing dental handpieces
The following tables show the cycles that were validated for Class S and Class B, including sterilization temperature, sterilization time in minutes and dry time in minutes and maximum loads:
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213080: T-Edge 10, T-Edge 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213080
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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