510(k) · Cleared
Recalled · Class II · 2014Steri-Vac #400C Gas Sterilizer
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 Nov 2, 1981 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 1981
- Review
- 20 days
- Class
- Class II
- Product code
- FLF
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK812867 Steri-Vac #400C Gas Sterilizer3M Company · 1981
- Descendant · cites it directly · 2 of its ownK150646 EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK192978 EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK170432 Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See all- K150646EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2015 · cites it directly2descendants
- K192978EOGas 4 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2020 · 2 generations on0descendants
- K170432Anprolene AN75 Ethylene Oxide Gas SterilizerAndersen Sterilizers, Inc. · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K812867 | Steri-Vac #400C Gas Sterilizer | 3M Company | 1981 | — |
| +1 | K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2015 | — |
| +2 | K192978 | EOGas 4 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2020 | — |
| +2 | K170432 | Anprolene AN75 Ethylene Oxide Gas Sterilizer | Andersen Sterilizers, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150646 | EOGas 4 Ethylene Oxide Gas Sterilizer | 2015 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 17, 2014 | Class II | Z-1318-2014 | Device Design | Recently, 3M received a single report of a potential exposure to Ethylene Oxide (EO) at a hospital installation involving 3M" Steri-Vac" Gas Sterilizers. The cause was traced to a rare situation involving a failure of the EO cartridge… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K150646 (Andersen Sterilizers, Inc., 2015) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FLF devicesFLF Sterilizer, Ethylene-Oxide Gas: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K812867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K812867: Steri-Vac #400C Gas Sterilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K812867
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026