510(k) · Cleared
Cleared3M Steri-Vac Sterilizer/Aerator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · FLF Sterilizer, Ethylene-Oxide Gas
Cleared on Jan 8, 2015 as substantially equivalent to K941748 (3M Health Care, Ltd., 1994) after a 164-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 8, 2015
- Review
- 164 days
- Class
- Class II
- Product code
- FLF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941748 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941748 Steri-Vac Gas Sterilizer Model 8XL3M Health Care, Ltd. · 1994 · Recalled
- This deviceK142034 3M Steri-Vac Sterilizer/Aerator3M Company · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941748 | Steri-Vac Gas Sterilizer Model 8XL | 3M Health Care, Ltd. | 1994 | 3 |
| 0 (this device) | K142034 | 3M Steri-Vac Sterilizer/Aerator | 3M Company | 2015 | — |
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? (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 |
|---|---|---|---|
| * | K941748 | Steri-Vac Gas Sterilizer Model 8XLSummary page 4…d GS8 Classification Name: Sterilizer, Ethylene-Oxide Gas (21 CFR § 880.6860) Device Class: II Product Code: FLF Predicate Devices: K941748 – Steri-Vac™ 8XL EO Gas Sterilizer Description of Device: The 3M Steri-Vac™ GS5 and 3M Steri-Vac™ GS8 models are traditional et… | 1994 |
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 a recall.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles: Model Cycle Gas Expose Time (min.) Temperature (deg C) EO Concentration (mg/L) Relative Humidity (%)* GS5 Cool 270 38 736 40-80 Warm 60 55 736 40-80 GS8 Cool 270 38 759 40-80 Warm 60 55 759 40-80 Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of…
Read the full statement (97 words)
The 3M™ Steri-Vac™ Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices in the following cycles:
Model Cycle Gas Expose Time (min.) Temperature (deg C) EO Concentration (mg/L) Relative Humidity (%)*
GS5 Cool 270 38 736 40-80
Warm 60 55 736 40-80
GS8 Cool 270 38 759 40-80
Warm 60 55 759 40-80
Single or dual channel rigid and flexible scopes can be sterilized with non-lumened medical instruments in any of the GS sterilizer cycles provided the cycle parameters match the instrument’s sterilization instructions. The load per cycle should not exceed 20 lumens.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142034 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142034: 3M Steri-Vac Sterilizer/Aerator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142034
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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