510(k) · Cleared
ClearedT-Top 10 & T-Top T-Top 11
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuttnauer U.S.A Co, Ltd. · FLE Sterilizer, Steam
Cleared on Nov 27, 2023 as substantially equivalent to K213080 (Tuttnauer, Ltd., 2022) after an 88-day review. Its family tree reaches back 7 generations to 2001. 1 later device descends from it.
- Decided
- Nov 27, 2023
- Review
- 88 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K003470 (2001). 16 ancestors in all, the oldest K850264 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 6 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 5 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 4 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 3 generations backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- 2 generations backK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- 1 generation backK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- This deviceK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK250168 Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
Most influential descendants
Showing 1 of 1 · See all- K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −6 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −5 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −4 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −3 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| −2 | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| −1 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| 0 (this device) | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| +1 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K213080 | T-Edge 10, T-Edge 11Summary page 5…tion Regulation Class 510K no. name Number Name T-Edge 10 & FLE 21CFR Steam Class II K213080 T-Edge 11 880.6880 Sterilizer Page 2 of 19 === Page 6… | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | 2025 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K250168 (Lucas Lifecare, 2025) has gone furthest, with 0 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. 2023, 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-Top 10 & T-Top 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 & dental offices).
The T-Top 10 and T-Top 11 devices are validated for use in:
• Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
• Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232658: T-Top 10 & T-Top T-Top 11.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232658
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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