510(k) · Cleared
ClearedMontgomery Radiopaque Laryngeal Keel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Medical Products, Inc. · FWN Prosthesis, Larynx (Stents And Keels)
Cleared on Aug 9, 1996 after a 29-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 9, 1996
- Review
- 29 days
- Class
- Class II
- Product code
- FWN
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 FWN? 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? (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 |
|---|---|---|---|
| * | — | Montgomery Laryngeal Keel 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.
How does its category compare?
All FWN devicesFWN Prosthesis, Larynx (Stents And Keels): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FWN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · FWN
Too few FWN 510(k)s in any year since 2007 to give a median.
Recalls per year · FWN
No recall names FWN since 2007.
Adverse event reports per year · FWN
2in 2018
MAUDE reports naming product code FWN, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1. To repair simple anterior glottic stenosis due to anterior commissure web formation.
2. To prevent anterior glottic stenosis in situations where anterior commissure stenosis is fikely to occur (eg, following extralaryngeal or endolaryngeal trauma with loss of anterior commissure).
3. To prevent the anterior glotlic stenosis immediately following removal of the Monigomery Laryngeal Stent.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962693 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962693: Montgomery Radiopaque Laryngeal Keel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962693
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026