510(k) Report

510(k) · Cleared

Cleared

Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand)

K954771510(k) TraditionalCleared May 9, 1996205-day reviewClass I21 CFR 868.5790

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

Laerdal Medical Corp. · BSR Stylet, Tracheal Tube

Cleared on May 9, 1996 as substantially equivalent to K922842 (Laerdal California, Inc., 1992) after a 205-day review. Its family tree reaches back 1 generation to 1992.

Decided
May 9, 1996
Review
205 days
Class
Class I
Product code
BSR
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K922842 (1992). No later device cites it as a predicate yet.

K922842 · Stylet and Tracheal Lightwand (STL) · Laerdal California, Inc. · 199219901992199419961998
K922842 · Stylet and Tracheal Lightwand (STL) · Laerdal California, Inc. · 19920
  1. Root · 1 generation backK922842 Stylet and Tracheal Lightwand (STL)Laerdal California, Inc. · 1992
  2. This deviceK954771 Trachlight Stylet & Tracheal Lightwand (Original Application Name…Laerdal Medical Corp. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K922842Stylet and Tracheal Lightwand (STL)Laerdal California, Inc.1992—
0 (this device)K954771Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett &…Laerdal Medical Corp.1996—
FIG. 1 — Lineage of K954771, 1992–1996Source: 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), 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 BSR? 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? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K922842Stylet and Tracheal Lightwand (STL)
Summary page 2
…ution: (See Attachment 3) a. California Medical Products, Inc. Stylet and Tracheal Lightwand (now owned and manufactured by Laerdal Medical Corporation) and reviewed on K922842/A. b. Fiberoptic Medical Products, Inc. Imagica Fiberoptic Lighted Stylet. c. Aaron Medical Industries, AARON Pediatric Surch-L…
Laerdal California, Inc.1992—
*—Fiberoptic Medical Products, Inc. Imagica Fiberoptic Lighted Stylet
Named without a submission number
—
*—Aaron Medical Industries, AARON Pediatric Surch-Lite
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.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All BSR devices

BSR Stylet, Tracheal Tube: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · BSR

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSR

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

Recalls per year · BSR

3in 2024

2008: 32011: 12014: 12015: 22016: 12024: 3
2007high 3 (2008) · low 0 (2007)2026

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

Adverse event reports per year · BSR

18in 2025

2007: 162008: 92009: 72010: 182011: 182012: 272013: 352014: 552015: 222016: 92017: 122018: 152019: 182020: 52021: 112022: 52023: 192024: 312025: 18
2007high 55 (2014) · low 5 (2020)2025

MAUDE reports naming product code BSR, 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—016
20080—39
20090—07
20100—018
20110—118
20120—027
20130—035
20140—155
20150—222
20160—19
20171—012
20180—015
20190—018
20200—05
20210—011
20220—05
20230—019
20240—331
20250—018
20260—0—

What is it indicated for?

The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Laerdal Medical Corp.

11 FDA decisions under this applicant name. See the company

  • K001742Resusci Inflate-a-Shield CPR BarrierLaerdal Medical Corp. · 2000
  • K962361Trachlight Stylet and Tracheal LightwandLaerdal Medical Corp. · 1996
  • K954609Heartstart 911Laerdal Medical Corp. · 1996
  • K950698Lsu 2000 Portable Suction UnitLaerdal Medical Corp. · 1995
  • K933048Laerdal (TM) Pocket Mask, ModificationLaerdal Medical Corp. · 1993

Recent decisions in BSR

The BSR category page

  • K162729Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook…Cook Incorporated · 2017
  • K962361Trachlight Stylet and Tracheal LightwandLaerdal Medical Corp. · 1996
  • K943104Molloy Intubating StyletteMolloy Corp. · 1996
  • K955238Rusch Schroeder Endotracheal Tube StyleRusch Intl. · 1996
  • K953677Lighted Flexguide (Modification)Scientific Sales Intl., Inc. · 1995

https://510kreport.com/device/K954771 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954771: Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954771

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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