510(k) · Cleared
ClearedAstell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astell Scientific Limited · FLE Sterilizer, Steam
Cleared on Mar 2, 2018 as substantially equivalent to K111736 (Tuttnauer Co., Ltd., 2011) after a 395-day review. Its family tree reaches back 5 generations to 2001.
- Decided
- Mar 2, 2018
- Review
- 395 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K003470 (2001). 9 ancestors in all, the oldest K850264 (1985). No later device cites it as a predicate yet.
- Root · 5 generations backK003470 Ehs Series Table Top Autoclave, Models 2540 and 3870Tuttnauer Co., Ltd. · 2001
- 4 generations backK032192 Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door…Tuttnauer U.S.A Co, Ltd. · 2004
- 3 generations backK063711 Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120…Tuttnauer Co., Ltd. · 2007
- 2 generations backK090783 Tuttnauer Elara-11 Pre-Vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd. · 2009
- 1 generation backK111736 Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesTuttnauer Co., Ltd. · 2011
- This deviceK170304 Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizersAstell Scientific Limited · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K003470 | Ehs Series Table Top Autoclave, Models 2540 and 3870 | Tuttnauer Co., Ltd. | 2001 | — |
| −4 | K032192 | Pre-Vacuum Autoclave with Steam Generator and Vertical Sliding Door, Models… | Tuttnauer U.S.A Co, Ltd. | 2004 | — |
| −3 | K063711 | Tuttnauer Prevacuum Steam Heated Autoclave, Models 6990 SP-1A, 66120 SP-1A… | Tuttnauer Co., Ltd. | 2007 | — |
| −2 | K090783 | Tuttnauer Elara-11 Pre-Vacuum Tabletop Autoclave | Tuttnauer U.S.A Co, Ltd. | 2009 | — |
| −1 | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop Autoclaves | Tuttnauer Co., Ltd. | 2011 | — |
| 0 (this device) | K170304 | Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers | Astell Scientific Limited | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FLE device
- #1 K250168 Life Ultra 25L Tabletop Mono Chamber Steam…score 12.7 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K111736 | Tuttnauer EZ Plus Series Electronic Tabletop AutoclavesSummary page 5…UMB 240 Autoclaves/Sterilizers Classification Name: Steam Sterilizer: Class II Device-21 C.F.R. § 880.6880 Predicate Device 510(k) No: K111736 Predicate Device Trade Name: Tuttnauer EZ Plus Series Electronic Table Top Autoclaves (EZ9 Plus,… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- 3 other devices also cite its predicate K111736.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FLE
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FLE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FLE
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLE
71in 2025
MAUDE reports naming product code FLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 67 | 1 | 19 |
| 2008 | 1 | — | 1 | 21 |
| 2009 | 8 | 109 | 0 | 19 |
| 2010 | 2 | — | 0 | 20 |
| 2011 | 5 | 141 | 1 | 63 |
| 2012 | 5 | 111 | 1 | 69 |
| 2013 | 5 | 241 | 2 | 112 |
| 2014 | 2 | — | 0 | 113 |
| 2015 | 3 | 302 | 1 | 68 |
| 2016 | 1 | — | 0 | 76 |
| 2017 | 3 | 233 | 0 | 63 |
| 2018 | 8 | 146 | 1 | 90 |
| 2019 | 5 | 192 | 2 | 91 |
| 2020 | 2 | — | 0 | 87 |
| 2021 | 5 | 147 | 1 | 81 |
| 2022 | 10 | 133 | 0 | 70 |
| 2023 | 7 | 88 | 0 | 66 |
| 2024 | 2 | — | 0 | 64 |
| 2025 | 4 | 184 | 0 | 71 |
| 2026 | 3 | 85 | 1 | — |
What is it indicated for?
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…
Read the full statement (311 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170304: Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170304
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026