510(k) · Cleared
ClearedTuttnauer Table-Top 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 Oct 29, 1997 as substantially equivalent to K833837 (Tuttnauer Co., Ltd., 1984) after a 41-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Oct 29, 1997
- Review
- 41 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K833837 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK833837 American Gold Series AutoclaveTuttnauer Co., Ltd. · 1984
- This deviceK973550 Tuttnauer Table-Top AutoclaveTuttnauer U.S.A Co, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K833837 | American Gold Series Autoclave | Tuttnauer Co., Ltd. | 1984 | — |
| 0 (this device) | K973550 | Tuttnauer Table-Top Autoclave | Tuttnauer U.S.A Co, Ltd. | 1997 | — |
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 |
|---|---|---|---|
| * | K833837 | American Gold Series AutoclaveSummary page 1…d to be substantially equivalent in safety and effectiveness to the Tuttnauer Model M series autoclave that 1s currently cleared and legally marketed under 510(k) number K833837. With the exception of the change from a ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism, t… | 1984 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K833837.
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 and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the “E” Series; these…
Read the full statement (118 words)
Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization.
The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the “E” Series; these cycles are pre-programmed, whereas in the “M” Series the user must manually set the parameters, however, these parameters are recommended in the labeling.
These autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.
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/K973550 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973550: Tuttnauer Table-Top Autoclave.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973550
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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