# K090783: Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Aug 20, 2009 after 150 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: 3 generations back to K003470 (2001). 4 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.

## Most influential descendants
- 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
- 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

## Indications for use
The ELARA- 11" is a table-top autoclave 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.

Source page: https://510kreport.com/device/K090783
Methodology: https://510kreport.com/methodology