510(k) Report

510(k) · Cleared

Cleared

Molloy Intubating Stylette

K943104510(k) TraditionalCleared Apr 18, 1996659-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

Molloy Corp. · BSR Stylet, Tracheal Tube

Cleared on Apr 18, 1996 after a 659-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Apr 18, 1996
Review
659 days
Class
Class I
Product code
BSR
Recalls
None
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 K943104Source: 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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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)

No FDA recall names this device.

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—

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
  • K955238Rusch Schroeder Endotracheal Tube StyleRusch Intl. · 1996
  • K953677Lighted Flexguide (Modification)Scientific Sales Intl., Inc. · 1995

https://510kreport.com/device/K943104 · printed Nov 4, 2026

Cite this page

510(k) Report. “K943104: Molloy Intubating Stylette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K943104

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