510(k) · Cleared
ClearedAnprolene AN75 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 Oct 31, 2017 as substantially equivalent to K150646 (Andersen Sterilizers, Inc., 2015) after a 260-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Oct 31, 2017
- Review
- 260 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.
Top candidate predicates for a new FLF device
- #1 K192978 EOGas 4 Ethylene Oxide Gas Sterilizerscore 0.6 · 2 generations · no Class I recall
What was it cleared against? (2)
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 5…69340-9). Primary Predicate Device - EOGas 4 Sterilizer Device Name EOGas 4® Ethylene Oxide Gas Sterilizer 510(k) number K150646 Manufacturer Andersen Sterilizers, Inc. For the subject device, the sterilization temperature, steriliza… | 2015 |
| * | — | B-2270/AN70 Anprolene Sterilizer Named without a submission number |
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 36 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. 2017, 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 Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation. The 12 hour cycle at 20-29ºC in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are…
Read the full statement (284 words)
The Anprolene AN75 Ethylene Oxide Gas Sterilizer is intended for use in hospitals and other human healthcare settings. It is designed to sterilize reusable medical devices that are sensitive to moisture, heat, chemical corrosion, or radiation.
The 12 hour cycle at 20-29ºC in the Anprolene AN75 Ethylene Oxide Gas Sterilizer is for surface sterilization of medical devices, including mated surfaces. The critical process parameters for the cycle are summarized in Table 1.
Table 1. Critical sterilization cycle parameters in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
EO Amount: 17.6 g ± 5%; Temperature: 20-29°C (68-84ºF); Relative Humidity: 35-70%; EO Exposure Time: 12 hours; Total Cycle Time: 14 hours
Maximum loads of specific materials and devices that have been validated are listed in Table 2. All validated maximum loads were processed without additional devices in the sterilizer.
Table 2. Load and material types validated in the Anprolene AN75 Ethylene Oxide Gas Sterilizer
Device Type: Metal. Maximum Load: 24 lbs (11 kg). Device Examples: Delicate sharps and surgical instruments, including those with hinges and mated surfaces. Required Aeration: Metal instruments do not absorb EO; Follow pouch or wrap manufacturer’s instructions (Example: Sterisheet® wraps require ≥ 6 hours at 20-29°C).
Device Type: Plastic. Maximum Load: 3.5 lbs (1.6 kg). Device Examples: Reusable power cords, trocars. Required Aeration: Follow manufacturer’s instructions; 24 hours at 20-29°C.
Device Type: Fabric. Maximum Load: 3.0 lbs (1.4 kg). Device Examples: Reusable cloth gowns, towels. Required Aeration: Follow manufacturer’s instructions; 24 hours at 20-29°C.
Reusable medical devices must be aerated following the instructions of device manufacturers and packaging material manufacturers, then released for use after sterilization based on successful inactivation of an EZTest®- Gas Biological Indicator in the Anprolene SteriTest process challenge device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170432: Anprolene AN75 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/K170432
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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