510(k) · Cleared
ClearedPre-vacuum Tabletop Autoclave
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 Jan 15, 2015 as substantially equivalent to K090783 (Tuttnauer U.S.A Co, Ltd., 2009) and 3 other predicates after a 58-day review. Its family tree reaches back 5 generations to 2001. 6 later devices descend from it.
- Decided
- Jan 15, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K003470 (2001). 14 ancestors in all, the oldest K850264 (1985). 6 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 4 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 3 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 2 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 1 generation backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- This deviceK143311 Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015
- Descendant · cites it directly · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK232658 T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK151597 Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016
- Descendant · 3 generations on · 0 of its ownK250168 Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025
- Descendant · cites it directly · 0 of its ownK222608 Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WSTuttnauer, Ltd. · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · cites it directly2descendants
- K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd. · 2023 · 2 generations on1descendant
- K151597Family of Steam Sterilizers B 28 seriesCefla S.C. · 2016 · cites it directly1descendant
- K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare · 2025 · 3 generations on0descendants
- K222608Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WSTuttnauer, Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −4 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −3 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −2 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −1 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| 0 (this device) | K143311 | Pre-vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2015 | — |
| +1 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
| +2 | K232658 | T-Top 10 & T-Top T-Top 11 | Tuttnauer U.S.A Co, Ltd. | 2023 | — |
| +1 | K151597 | Family of Steam Sterilizers B 28 series | Cefla S.C. | 2016 | — |
| +3 | K250168 | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | Lucas Lifecare | 2025 | — |
| +1 | K222608 | Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS | Tuttnauer, Ltd. | 2022 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveSummary page 6….F.R. § 880.6880 Product Code - FLE Substantial Equivalence: The ELARA-11 and Model 5075 HSG are claimed to be substantially equivalent to the autoclaves cleared under K090783 and K063711. Like these autoclaves, the ELARA-11 and Model 5075 HSG contain an electronic control panel that permits automatic us… | 2009 |
| * | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A…Summary page 6…6880 Product Code - FLE Substantial Equivalence: The ELARA-11 and Model 5075 HSG are claimed to be substantially equivalent to the autoclaves cleared under K090783 and K063711. Like these autoclaves, the ELARA-11 and Model 5075 HSG contain an electronic control panel that permits automatic usage, and con… | 2007 |
| * | K050263 | Millennium Series, Including Millennium B, B+, B2 and BUSummary page 6…(K090783). Further, all devices use steam as the sterilization agent. The autoclaves are substantially equivalent to the Millennium B pre-vacuum autoclave cleared under K050263 based on general principles of operation as a steam sterilizer, and specifically for the device’s electronic control, pre-vacuum… | 2006 |
| * | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesSummary page 6…ce’s electronic control, pre-vacuum operation, and post-vacuum drying stage. The autoclaves substantially equivalent to the Tuttnauer EZ series autoclaves cleared under K111736. This is based on general principles of operation as a a steam sterilizer, and specifically for the device’s electronic control a… | 2011 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K213080 (Tuttnauer, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K090783.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ELARA-11 is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms. The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4. The…
Read the full statement (185 words)
The ELARA-11 is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms.
The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.
The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.
The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.
The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.
The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.
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/K143311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143311: Pre-vacuum Tabletop Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143311
Report an extraction error
Are you the manufacturer?
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