510(k) Report

510(k) · Cleared

Cleared

Tracheal Tube Fixation Device

K843790510(k) TraditionalCleared Mar 11, 1985165-day reviewClass I21 CFR 868.5770

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

Laerdal California, Inc. · CBH Device, Fixation, Tracheal Tube

Cleared on Mar 11, 1985 after a 165-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
Mar 11, 1985
Review
165 days
Class
Class I
Product code
CBH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2019: 1 descendant cleared1990200020102020
  1. This deviceK843790 Tracheal Tube Fixation DeviceLaerdal California, Inc. · 1985
  2. Descendant · cites it directly · 0 of its ownK190630 SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC · 2019

Most influential descendants

Showing 1 of 1 · See all
  • K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843790Tracheal Tube Fixation DeviceLaerdal California, Inc.1985—
+1K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
FIG. 1 — Lineage of K843790, 1985–2019Source: 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.

Planning a device in CBH? 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
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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
K190630SolidAIRity III Airway Stabilization SystemSecurisyn Medical, LLC20190

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, K190630 (Securisyn Medical, LLC, 2019) has gone furthest, with 0 descendants of its own.

How does its category compare?

All CBH devices

CBH Device, Fixation, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CBH

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CBH

Too few CBH 510(k)s in any year since 2007 to give a median.

Recalls per year · CBH

4in 2024

2007: 22024: 4
2007high 4 (2024) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · CBH

62in 2025

2007: 222008: 452009: 232010: 142011: 352012: 242013: 402014: 402015: 172016: 262017: 322018: 322019: 302020: 672021: 272022: 472023: 222024: 202025: 62
2007high 67 (2020) · low 14 (2010)2025

MAUDE reports naming product code CBH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—222
20080—045
20090—023
20100—014
20110—035
20120—024
20130—040
20141—040
20150—017
20160—026
20170—032
20180—032
20190—030
20200—067
20210—027
20220—047
20230—022
20240—420
20250—062
20260—0—

More from Laerdal California, Inc.

5 FDA decisions under this applicant name. See the company

  • K941578Statvac Portable Suction UnitLaerdal California, Inc. · 1994
  • K922842Stylet and Tracheal Lightwand (STL)Laerdal California, Inc. · 1992
  • K862875E-Vac (TM)Laerdal California, Inc. · 1986
  • K832990Stifnick Immobilizing CollarLaerdal California, Inc. · 1983

Recent decisions in CBH

The CBH category page

  • K140097Amt Endotracheal Tube Bridle Retention SystemApplied Medical Technology, Inc. · 2014
  • K964399Dale Endotracheal Tube Holder 270/280Dale Medical Products, Inc. · 1997
  • K942529Hci Tube StabilizerHealth Care Contracts, Inc. · 1995
  • K951491Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsDale Medical Products, Inc. · 1995
  • K950930Trache-TiteThe Varner Group, Inc. · 1995

https://510kreport.com/device/K843790 · printed Nov 5, 2026

Cite this page

510(k) Report. “K843790: Tracheal Tube Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843790

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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