# K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer Co., Ltd.
- Decided: Dec 8, 2011 after 171 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: 4 generations back to K003470 (2001). 8 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090783: Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave, Tuttnauer U.S.A Co, Ltd. (2009) Summary page 1.
- K063711: Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A, 69150 SP-2A, 69120 L Usa SP-2A, 69180 SP-2HA, Tuttnauer Co., Ltd. (2007) Summary page 1.
- K021504: Tuttnauer Ehs Series Table-Top Autoclave, Model 2540, Tuttnauer U.S.A Co, Ltd. (2002) Summary page 1.
- K993856: Tuttnauer Electronic Autoclave, Models E, EA, EK, Eka, EP, Tuttnauer U.S.A Co, Ltd. (2001) Summary page 1.

## Most influential descendants
- K143311: Pre-vacuum Tabletop Autoclave (2015), 6 descendants of its own
- K213080: T-Edge 10, T-Edge 11 (2022), 2 descendants of its own
- K232658: T-Top 10 & T-Top T-Top 11 (2023), 1 descendant of its own
- K213457: Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 (2022), 1 descendant of its own
- K151597: Family of Steam Sterilizers B 28 series (2016), 1 descendant of its own

## Indications for use
The EZ Plus Series autoclaves are autoclaves 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, and medical clinics; in first aid rooms; and in small laboratories. Key program features, including sterilization times, temperature, maximum load sizes, and recommended use of each program are listed in the following chart:

Source page: https://510kreport.com/device/K111736
Methodology: https://510kreport.com/methodology