510(k) · Cleared
ClearedTuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP
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 Feb 9, 2001 as substantially equivalent to K920478 (Tuttnauer Co., Ltd., 1993) after a 452-day review. Its family tree reaches back 1 generation to 1993. 11 later devices descend from it.
- Decided
- Feb 9, 2001
- Review
- 452 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920478 (1993). 11 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK920478 Tuttnauer Lsi (Automatic)Tuttnauer Co., Ltd. · 1993
- This deviceK993856 Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EPTuttnauer U.S.A Co, Ltd. · 2001
- Descendant · cites it directly · 10 of its ownK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- Descendant · 2 generations on · 6 of its ownK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · 2 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · 3 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 ownK213457 Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort…Fort Defiance Industries, LLC · 2022
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K111736Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011 · cites it directly10descendants
- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · 2 generations on6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 2 generations on2descendants
- K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023 · 3 generations on1descendant
- K213457Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries…Fort Defiance Industries, LLC · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920478 | Tuttnauer Lsi (Automatic) | Tuttnauer Co., Ltd. | 1993 | — |
| 0 (this device) | K993856 | Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP | Tuttnauer U.S.A Co, Ltd. | 2001 | — |
| +1 | 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 | — |
| +2 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| +3 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| +2 | K213457 | Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance… | Fort Defiance Industries, LLC | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K920478 | Tuttnauer Lsi (Automatic)Summary page 1…ent to the following currently cleared and legally marketed autoclave: Company Product Name 510(k) Clearance Number Tuttnauer USA Co. Ltd. E Series Electronic Autoclave K920478% With the exception of changes to the automated program cycle times and the labeling to allow sterilization of dental handpieces… | 1993 |
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | 2011 | 10 |
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?
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?
Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid meta) instruments, solid metal hinged instrurnents, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121°C at 30 minutes end 16 psi). These cycles…
Read the full statement (104 words)
Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid meta) instruments, solid metal hinged instrurnents, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121°C at 30 minutes end 16 psi). These cycles are pre-programmed and are recommended in the labeling.
Tuttnauer E Series Electronic Table-top Autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.68%0.
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/K993856 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993856: Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993856
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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