# K170304: Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers

- Pathway: 510(k) (Traditional)
- Applicant: Astell Scientific Limited
- Decided: Mar 2, 2018 after 395 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). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111736: Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves, Tuttnauer Co., Ltd. (2011) Summary page 5.

## Indications for use
A steam sterilizer (Autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam. Typical applications: Metal Medical Instruments (Unwrapped) Metal Medical Instruments (Wrapped) Glassware (Unwrapped) Hand Pieces (Pouches) The electronic control has four pre-programmed sterilization cycles. The four pre-programmed sterilization cycles are for: Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes Cycle 2; Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes Cycle 3; Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes The four pre-programmed cycles are for: Cycle 1; Metal Medical Instruments (Unwrapped); 134°C for 3 minutes; Drying Time 15 minutes Maximum Load: Shelf rack can accommodate 4 instrument trays instruments they have to be layered down in an open position. All instruments have to remain apart with a minimum distance of 1 cm. Maximum weight/tray: 2.5 kg, Maximum load/cycle: 10 kg Cycle 2; Metal Medical Instruments (Wrapped); 134°C for 4 minutes; Drying time 30 minutes Maximum Load: Shelf rack can accommodate 2 pouch racks. Pouches have to stand on their side and not touching each other. Leave at least 2 cm between each item. Maximum weight/rack: 2.5 kg Maximum load/cycle: 5 kg Cycle 3; Glassware (Unwrapped); 121°C for 30 minutes; Drying time 15 minutes Shelf rack can accommodate 4 trays. Glassware have to be placed upside down with a minimum distance of 1 cm. Maximum weight/tray: 2.5 kg Maximum load/cycle: 10 kg Cycle 4; Hand pieces; (Pouches) 134°C for 4 minutes; Drying time 15 minutes Maximum Load: Shelf rack can accommodate 2 pouch racks. Pouches have to stand on their side and not touching each other. Leave at least 2 cm between each item. Maximum weight/rack: 2.5 kg Maximum load/cycle: 5 kg.

Source page: https://510kreport.com/device/K170304
Methodology: https://510kreport.com/methodology