510(k) Report

510(k) · Cleared

Cleared

Salivary Bypass Tube

K841350510(k) TraditionalCleared Jul 26, 1984115-day review

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

E. Benson Hood Laboratories, Inc.

Cleared on Jul 26, 1984 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Jul 26, 1984
Review
115 days
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared19801990200020102020
  1. This deviceK841350 Salivary Bypass TubeE. Benson Hood Laboratories, Inc. · 1984
  2. Descendant · cites it directly · 0 of its ownK130736 Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC · 2013

Most influential descendants

Showing 1 of 1 · See all
  • K130736Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC · 2013 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K841350Salivary Bypass TubeE. Benson Hood Laboratories, Inc.1984—
+1K130736Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
FIG. 1 — Lineage of K841350, 1984–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K130736Blom-Singer Adjustable BI-Fianged Fistula ProsthesisHelix Medical, LLC20130

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?

  • Of its descendants, K130736 (Helix Medical, LLC, 2013) has gone furthest, with 0 descendants of its own.

More from E. Benson Hood Laboratories, Inc.

6 FDA decisions under this applicant name. See the company

  • K983878Czaja-Mccaffrey Rigid Stent Introducer/EndoscopeE. Benson Hood Laboratories, Inc. · 1999
  • K841349Esophageal TubeE. Benson Hood Laboratories, Inc. · 1984
  • K841266Montgomery Tracheal T-TubeE. Benson Hood Laboratories, Inc. · 1984
  • K841347Laryngeal StentE. Benson Hood Laboratories, Inc. · 1984
  • K841348Umbrella KeelE. Benson Hood Laboratories, Inc. · 1984

https://510kreport.com/device/K841350 · printed Nov 6, 2026

Cite this page

510(k) Report. “K841350: Salivary Bypass Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K841350

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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