510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Stylet Sheath with Locking Cap and Reusable Battery Operated Light Source

K944729510(k) TraditionalCleared Dec 21, 199486-day reviewClass I21 CFR 868.5790Recalls 5

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

Coast Medical, Inc. · BSR Stylet, Tracheal Tube

Cleared on Dec 21, 1994 after an 86-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 5 times.

Decided
Dec 21, 1994
Review
86 days
Class
Class I
Product code
BSR
Recalls
5
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K944729Source: FDA 510(k) database · 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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  • 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 13, 2015Class IIZ-1556-2015PackagingVital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Mar 13, 2015Class IIZ-1557-2015PackagingVital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.
Aug 11, 2008Not classifiedZ-2454-2008Device DesignLight protector may detach from lighted stylet during intubation.
Aug 11, 2008Not classifiedZ-2455-2008Device DesignLight protector may detach from lighted stylet during intubation.
Aug 11, 2008Not classifiedZ-2456-2008Device DesignLight protector may detach from lighted stylet during intubation.

No ancestor or descendant has a Class I 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—

More from Coast Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K952243Extension Set/I.V. SetCoast Medical, Inc. · 1995
  • K943270Surface Temperature ProbesCoast Medical, Inc. · 1994
  • K943495Disposable Esophageal StethoscopeCoast Medical, Inc. · 1994
  • K943110Gas Sampling InterfacesCoast Medical, Inc. · 1994

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
  • K954771Trachlight Stylet & Tracheal Lightwand (Original Application Name: Stylett & Tracheal Lightwand)Laerdal Medical Corp. · 1996
  • K943104Molloy Intubating StyletteMolloy Corp. · 1996
  • K955238Rusch Schroeder Endotracheal Tube StyleRusch Intl. · 1996

https://510kreport.com/device/K944729 · printed Nov 3, 2026

Cite this page

510(k) Report. “K944729: Stylet Sheath with Locking Cap and Reusable Battery Operated Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K944729

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026