510(k) · Cleared
ClearedAMSCO 700 Steam Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FLE Sterilizer, Steam
Cleared on Jun 24, 2026 as substantially equivalent to K232485 (Steris, 2023) after an 85-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Jun 24, 2026
- Review
- 85 days
- Class
- Class II
- Product code
- FLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K232485 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backK232485 AMSCO 600 Steam SterilizerSteris · 2023
- This deviceK261055 AMSCO 700 Steam SterilizerSTERIS Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K232485 | AMSCO 600 Steam Sterilizer | Steris | 2023 | — |
| 0 (this device) | K261055 | AMSCO 700 Steam Sterilizer | STERIS Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K232485 | AMSCO 600 Steam SterilizerSummary page 7…Sterilizer Automated Loading System Classification Number: 21 CFR 880.6880 Product Code: FLE, PEC 2. Predicate Device K232485 AMSCO 600 Steam Sterilizer 3. Description of Device The AMSCO 700 Steam Sterilizer uses saturated steam, generated from a ho… | 2023 |
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?
- Its one ancestor has no recall.
How does its category compare?
All FLE devicesFLE Sterilizer, Steam: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
The AMSCO 700 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles: Table 1. AMSCO 700 Steam Sterilizer sterilization cycles and cycle values Sterilize Cycles Sterilize Time Dry Time Maximum Recommended Load Temperature Fabric Packs. Refer to Table 2 for Prevac 270°F (132°C) 4 minutes 20 minutes recommended quantities. Double…
Read the full statement (352 words)
The AMSCO 700 Steam Sterilizers are designed for sterilization of heat and moisture-stable materials used in healthcare facilities and are equipped with the following factory-programmed cycles:
Table 1. AMSCO 700 Steam Sterilizer sterilization cycles and cycle values
Sterilize
Cycles Sterilize Time Dry Time Maximum Recommended Load
Temperature
Fabric Packs. Refer to Table 2 for
Prevac 270°F (132°C) 4 minutes 20 minutes
recommended quantities.
Double wrapped instrument trays, maximum
Prevac 270°F (132°C) 4 minutes 30 minutes weight 25 lbs. (11.3 kg) each and Fabric Packs.
See Table 2 for maximum quantities.
Prevac 270°F (132°C) 4 minutes 5 minutes Single Fabric Pack.
Double wrapped instrument trays, maximum
Prevac 275°F (135°C) 3 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities.
Double wrapped instrument trays, maximum
Prevac 270°F (132°C) 10 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities.
Prevac-
270°F (132°C) 4 minutes 1 minute Immediate use – single unwrapped tray
IUSS
Double wrapped instrument trays, maximum
Gravity 270°F (132°C) 15 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities.
Double wrapped instrument trays, maximum
Gravity 250°F (121°C) 30 minutes 30 minutes weight 25 lbs. (11.3 kg) each. Refer to Table 2
for recommended quantities.
Warm-Up 270°F (132°C) 3 minutes 1 minute N/A
DART 270°F (132°C) 3.5 minutes 1 minute Bowie-Dick Test Pack, DART Test Pack
Leak Test N/A N/A N/A N/A
The maximum quantities of wrapped instrument trays or fabric packs for each proposed model are as follows:
Table 2. AMSCO 700 Steam Sterilizer maximum load per sterilizer size
Wrapped
Sterilizer Size Fabric Packs
Instrument Trays
26” x 26” x 39” 9 12
26” x 26” x 51” 12 16
26” x 26” x 63” 15 20
The Automated Load and Unload System (ALUS) provides semi-automated loading and unloading from an AMSCO 700 steam sterilizer when a cycle is complete. Alternatively, the ALUS may also be used to provide automatic unloading only in combination with manual loading. The ALUS can start a cycle automatically when equipped with the optional bar code reader.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261055 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261055: AMSCO 700 Steam Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261055
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026