# K032192: Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models 4472 EP-1V and 5596 EP-1V

- Pathway: 510(k) (Abbreviated)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Aug 12, 2004 after 392 days
- Product code: FLE (Sterilizer, Steam)
- Device class: 2
- Regulation: 21 CFR 880.6880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003470 (2001). 1 ancestor in all.
13 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003470: Ehs Series Table Top Autoclave, Models 2540 and 3870, Tuttnauer Co., Ltd. (2001) Summary page 1.

## Most influential descendants
- K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA (2007), 12 descendants of its own
- K090783: Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave (2009), 11 descendants of its own
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves (2011), 10 descendants of its own
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K032192
Methodology: https://510kreport.com/methodology