510(k) · Cleared
ClearedEOGas 4 Ethylene Oxide Gas Sterilizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Andersen Sterilizers, Inc. · FLF Sterilizer, Ethylene-Oxide Gas
Cleared on Nov 12, 2020 as substantially equivalent to K150646 (Andersen Sterilizers, Inc., 2015) after a 385-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Nov 12, 2020
- Review
- 385 days
- Class
- Class II
- Product code
- FLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K812867 (1981). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 FLF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K150646 | EOGas 4 Ethylene Oxide Gas SterilizerSummary page 6…EPA #69340-7). Predicate Device Device Name EOGas 4 Ethylene Oxide Gas Sterilizer 510(k) number K150646 Manufacturer Andersen Sterilizers, Inc. The principles of operation for the EOGas 4 Ethylene… | 2015 |
| † | K192980 | EOGas 4 Endo-SteriTest | 2020 |
| † | K930683 | Eztest-Gas | 1997 |
| † | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene… | 2019 |
| † | K151585 | Andersen EOGas 4 SteriTest | 2015 |
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 39 years and passes through 2 companies; a new generation was cleared every 34.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K150646.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · FLF
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · FLF
Too few FLF 510(k)s in any year since 2007 to give a median.
Recalls per year · FLF
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FLF
4in 2021
MAUDE reports naming product code FLF, 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 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 1 | — | 1 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 1 | 5 |
| 2013 | 0 | — | 2 | 3 |
| 2014 | 0 | — | 2 | 6 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EOGas 4 Ethylene Oxide Gas Sterilizer is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below: Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters EO Exposure Time: 3 hours; Total Cycle Time: 3.5 hours; EO Amount: 17.6 g + 5%; Temperature: 50°C +3°C; Relative Humidity: 35-70% EO Exposure Time: 6…
Read the full statement (240 words)
The EOGas 4 Ethylene Oxide Gas Sterilizer is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The critical process parameters for the two available cycles are summarized below:
Table 1. EOGas 4 Ethylene Oxide Sterilizer cycle parameters
EO Exposure Time: 3 hours; Total Cycle Time: 3.5 hours; EO Amount: 17.6 g + 5%; Temperature: 50°C +3°C; Relative Humidity: 35-70%
EO Exposure Time: 6 hours; Total Cycle Time: 7 hours
The differences between the two options are the length of EO gas exposure and the length of mandatory ventilation after gas exposure; the gas exposure is chosen based on the devices to be sterilized. The appropriate purge probe and process challenge device (PCD) must be used: EOGas 4 SteriTest for a 3-hour gas exposure, EOGas 4 Endo-SteriTest for a 6-hour gas exposure.
The EOGas 4 Ethylene Oxide Gas Sterilizer 3-hour gas exposure is used for surface sterilization of medical devices, including instruments with diffusion-restricted spaces (hinges or mated surfaces), as well as for the sterilization of endoscopes with working length shorter than 1100 mm as specified in the labeling. The EOGas 4 SteriTest PCD is used with the 3-hour gas exposure.
The EOGas 4 Ethylene Oxide Gas Sterilizer 6-hour gas exposure is used for sterilization of duodenoscopes and colonoscopes with working length longer than 1100 mm as specified in the labeling. The EOGas 4 Endo-SteriTest PCD is used with the 6-hour gas exposure.
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/K192978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192978: EOGas 4 Ethylene Oxide Gas Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192978
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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