510(k) · Cleared
ClearedTuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuttnauer, Ltd. · FLE Sterilizer, Steam
Cleared on Sep 20, 2022 as substantially equivalent to K181456 (Tuttnauer, Ltd., 2019) after a 145-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Sep 20, 2022
- Review
- 145 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K181456 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK181456 Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180…Tuttnauer, Ltd. · 2019
- This deviceK221227 Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120Tuttnauer, Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves | Tuttnauer, Ltd. | 2019 | — |
| 0 (this device) | K221227 | Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 | Tuttnauer, Ltd. | 2022 | — |
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 |
|---|---|---|---|
| * | K181456 | Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclavesSummary page 7…on Class 510k No. Name Number Name 4472, 5596, FLE 21CFR880.6880 Steam II K181456 6690 and Sterilizer 66120 Horizontal Autoclave Pa… | 2019 |
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.
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 Tuttnauer Horizontal autoclave models 4472, 5596, 6690 and 66120 are intended for use by health care providers to sterilize medical products by means of pressurized steam. The devices are autoclaves that are intended to provide sterilization of heat stable medical devices: wrapped and unwrapped (IUSS) solids, hollow and porous products.
The following tables show the validated cycles, including sterilization temperature, sterilization time (in minutes), dry time (in minutes) and maximum load for tools (in kilograms) and textile (in packs) for each of the models mentioned:
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/K221227 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221227: Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221227
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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