510(k) · Cleared
Recalled · Class I · 2011Sealflex Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Medical Systems · BSJ Mask, Gas, Anesthetic
Cleared on Dec 21, 1987 after a 33-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Dec 21, 1987
- Review
- 33 days
- Class
- Class I
- Product code
- BSJ
- Recalls
- 1 (1 Class I)
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 12, 2011 | Class I | Z-1058-2013 | Process change control | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling indicates. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All BSJ devicesBSJ Mask, Gas, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSJ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · BSJ
Too few BSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · BSJ
1in 2011
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSJ
2in 2025
MAUDE reports naming product code BSJ, 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 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 (1) | 1 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K874746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K874746: Sealflex Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K874746
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026