# K143311: Pre-vacuum Tabletop Autoclave

- Pathway: 510(k) (Traditional)
- Applicant: Tuttnauer U.S.A Co, Ltd.
- Decided: Jan 15, 2015 after 58 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: 5 generations back to K003470 (2001). 14 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 21 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 6.
- 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 6.
- K050263: Millennium Series, Including Millennium B, B+, B2 and BU, M.O. Com S.R.L. (2006) Summary page 6.
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves, Tuttnauer Co., Ltd. (2011) Summary page 6.

## Most influential descendants
- 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
- K151597: Family of Steam Sterilizers B 28 series (2016), 1 descendant of its own
- K250168: Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer (2025), 0 descendants of its own
- K222608: Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS (2022), 0 descendants 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, medical clinics; and in first aid rooms. The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4. The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4. The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4. The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals. The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3. The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.

Source page: https://510kreport.com/device/K143311
Methodology: https://510kreport.com/methodology