510(k) · Cleared
ClearedPre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models 4472 EP-1V and 5596 EP-1V
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 Aug 12, 2004 as substantially equivalent to K003470 (Tuttnauer Co., Ltd., 2001) after a 392-day review. Its family tree reaches back 1 generation to 2001. 13 later devices descend from it.
- Decided
- Aug 12, 2004
- Review
- 392 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003470 (2001). 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- This deviceK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- Descendant · cites it directly · 12 of its ownK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- Descendant · 2 generations on · 11 of its ownK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- Descendant · 2 generations on · 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 · 3 generations on · 2 of its ownK213080 T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K063711Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A…Tuttnauer Co., Ltd. · 2007 · cites it directly12descendants
- K090783Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009 · 2 generations on11descendants
- K111736Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011 · 2 generations on10descendants
- K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2015 · 2 generations on6descendants
- K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| 0 (this device) | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| +1 | 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 | — |
| +2 | 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 | — |
| +3 | K213080 | T-Edge 10, T-Edge 11 | Tuttnauer, Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870Summary page 1…Company Product Name 5 10(k Clearance Number Tuttnauer USA Co. Ltd. EHS Series Pre-vacuum Autoclaves K003470 General Description: The Tuttnauer Model 4472 EP-IV and 5596 EP-IV Autoclaves are steam sterilizers that provide onboard steam… | 2001 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A… | 2007 | 12 |
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?
The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed (but not sealed) containers. It has the following automated program sterilization cycles: Program 1 (Flash - Porous) Parameters: - Sterilization temperature & Range: 270°F (270 - 276 F) - Sterilization time: 3 minutes -…
Read the full statement (618 words)
The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed (but not sealed) containers. It has the following automated program sterilization cycles:
Program 1 (Flash - Porous)
Parameters:
- Sterilization temperature & Range: 270°F (270 - 276 F)
- Sterilization time: 3 minutes
- Pressure & Range: 186 Kpa (186- 220 kPa); 12.3 psig (12.3 - 17.2 psig)
- Maximum load: two (2) 16 lb. unwrapped trays (per ST8:2001)
Program 2 (Flash - Nonporous)
Parameters:
- Sterilization temperature & Range: 270°F (270 - 276 0 F)
- Sterilization time: 10 minutes
- Pressure & Range: 186 kPa (186 -220 kPa); 12.3 psig (12.3 - 17.2 psig)
- Maximum load: two (2) 16 lb. unwrapped trays (per ST8:2001)
Program 3 (Wrapped - 270 0F)
For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 2700 F with drying cycle.
Parameters:
- Sterilization temperature & Range: 2700 F (270 - 276 0 F)
- Sterilization time: 4 minutes
- Dry time: 30 minutes
- Pressure & Range: 186 kPa (186- 220 kPa); 12.3 psig (12.3 - 17.2 psig)
- Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001)
Program 4 (Wrapped - 270 0F)
For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 270°F with drying cycle.
Parameters:
- Sterilization temperature & Range: 270°F (270 - 276 0 F)
- Sterilization time: 10 minutes
- Dry time: 20 minutes
- Pressure & Range: 186 kPa (186- 220 kPa); 12.3 psig (12.3-17.2 psig)
- Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001)
Program 6 (Wrapped 275°F)
For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 2750 F with drying cycle.
Parameters:
- Sterilization temperature & Range: 275°F (275 - 281 0 F)
- Sterilization time: 3 minutes
- Dry time: 20 minutes
- Pressure & Range: 214 kPa (214 -245 kPa); 16.3 psig (16.3-20.8 psig)
- Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001)
Program 6 (Wrapped - 2500F)
For sterilization of wrapped instruments, utensils, textiles and materials which the manufacturer recommends autoclaving at temperatures of up to 250°F with drying cycle.
Parameters:
- Sterilization temperature & Range: 250°F (250 - 256°F)
- Sterilization time: 30 minutes
- Dry time: 45 minutes
- Pressure & Range: 103 kPa (103-128 kPa); 0.2 psig (0.2 - 3.9 psig)
- Maximum load: two (2) 16 lb. wrapped trays or 8 towel packs (per ST8:2001)
Program 7 (Liquids - 250 0F) For non-clinical applications only
For sterilization of liquids which the manufacturer recommends autoclaving at temperatures of up to 250 0 F. For non-clinical applications only.
Parameters:
- Sterilization temperature & Range: 250°F (250 - 256 0 F)
- Sterilization time: 30 minutes
- Pressure & Range: 103 kPa (103- 128 kPa); 0.2 psig (0.2-3.9 psig)
- Maximum load: three (3) 1 liter flasks (per ST8:2001)
Program 8 (Bowie-Dick Test)
This is a test program, with fixed sterilization parameters of 273°F and 3.5 minutes which cannot be modified by the operator.
Parameters:
- Sterilization temperature & Range: 273°F (273-274 F)
- Sterilization time: 3.5 minutes
- Dry time: 2 minutes
- Pressure & Range: 207 kPa (207 Kpa); 15.3 psig (15.3 psig)
Program 9 (Air Leakage Test)
This test is intended to test air leakage to the chamber through the door seal or any other seals. This test is performed in vacuum phase.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032192 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032192: Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models 4472 EP-1V and 5596 EP-1V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032192
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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