510(k) · Cleared
ClearedBlom-Singer Adjustable BI-Fianged Fistula Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Helix Medical, LLC · LRC Instrument, Ent Manual Surgical
Cleared on Dec 17, 2013 as substantially equivalent to K841350 (E. Benson Hood Laboratories, Inc., 1984) after a 274-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Dec 17, 2013
- Review
- 274 days
- Class
- Class I
- Product code
- LRC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K841350 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK841350 Salivary Bypass TubeE. Benson Hood Laboratories, Inc. · 1984
- This deviceK130736 Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K841350 | Salivary Bypass Tube | E. Benson Hood Laboratories, Inc. | 1984 | — |
| 0 (this device) | K130736 | Blom-Singer Adjustable BI-Fianged Fistula Prosthesis | Helix Medical, LLC | 2013 | — |
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 LRC? 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 LRC device
- #1 K230258 BB 8 Sinus Dilation Kitscore 11.1 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K96268 | Montgomery Radiopaque Salivary Bypass Tube Number could not be read Summary page 1…edicate Devices The Blom-Singer® Adjustable Si-Flanged Fistula Prosthesis is substantially equivalent to the Montgomery Radiopaque Salivary Bypass Tube, cleared 5 10(k) K96268, and the Hood Laboratories Salivary Bypass Tube, cleared under K84 1350, with respect to indications for use, materials and mecha… | |
| * | K841350 | Salivary Bypass TubeSummary page 1…esis is substantially equivalent to the Montgomery Radiopaque Salivary Bypass Tube, cleared 5 10(k) K96268, and the Hood Laboratories Salivary Bypass Tube, cleared under K84 1350, with respect to indications for use, materials and mechanism of action. Confidential… | 1984 |
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 no recall.
How does its category compare?
All LRC devicesLRC Instrument, Ent Manual Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LRC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LRC
131in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LRC
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LRC
44in 2025
MAUDE reports naming product code LRC, 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 | 1 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 8 |
| 2010 | 2 | — | 0 | 11 |
| 2011 | 6 | 106 | 0 | 14 |
| 2012 | 7 | 50 | 0 | 48 |
| 2013 | 7 | 104 | 0 | 53 |
| 2014 | 3 | 29 | 0 | 53 |
| 2015 | 6 | 105 | 0 | 41 |
| 2016 | 3 | 100 | 0 | 39 |
| 2017 | 2 | — | 0 | 32 |
| 2018 | 1 | — | 0 | 42 |
| 2019 | 1 | — | 0 | 19 |
| 2020 | 4 | 131 | 0 | 20 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 1 | — | 0 | 25 |
| 2023 | 1 | — | 1 | 14 |
| 2024 | 0 | — | 1 | 51 |
| 2025 | 0 | — | 0 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Blom-Singere Adjustable Ri-Flanged Fistula Prosthesis is indicated for the management of hypopharyngeal fistulae. This is a short term medical device, normally intended for continuous use for not mare than 29 days. It needs periodic replacement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130736: Blom-Singer Adjustable BI-Fianged Fistula Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130736
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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