510(k) · Cleared
ClearedLorals
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Brazen Goods Inc. Dba Lorals · MSC Barrier, Std, Oral Sex
Cleared on Apr 22, 2022 as substantially equivalent to K091769 (Line One Laboratories, Inc., 2010) after a 220-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Apr 22, 2022
- Review
- 220 days
- Class
- Class II
- Product code
- MSC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990067 (1999). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K253662Lixi (LXOSFM1)Luwi, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990067 | Sheer Glyde Dams | Louise C. Myers | 1999 | — |
| −1 | K091769 | Trust Dam | Line One Laboratories, Inc. | 2010 | — |
| 0 (this device) | K212928 | Lorals | Brazen Goods Inc. Dba Lorals | 2022 | — |
| +1 | K253662 | Lixi (LXOSFM1) | Luwi, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
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 MSC? 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 MSC device
- #1 K253662 Lixi (LXOSFM1)score 12.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K091769 | Trust DamSummary page 4…TIFICATION Lorals are substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer Primary Predicate K091769 Trust Dam/Line One Laboratories, Inc. The predicate device has not been subject to a design… | 2010 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K253662 | Lixi (LXOSFM1) | 2026 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 12.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K253662 (Luwi, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091769.
How does its category compare?
All MSC devicesMSC Barrier, Std, Oral Sex: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MSC
2in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MSC
Too few MSC 510(k)s in any year since 2007 to give a median.
Recalls per year · MSC
No recall names MSC since 2007.
Adverse event reports per year · MSC
No MAUDE report names MSC since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Lorals are used as a barrier when engaging in oral/vaginal and oral/anal sex to help reduce the transmission of bodily fluids, harmful pathogens, and sexually transmitted infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212928 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212928: Lorals.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212928
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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