Cleared Traditional

K943104 - MOLLOY INTUBATING STYLETTE

K943104 is an FDA 510(k) clearance for MOLLOY INTUBATING STYLETTE, manufactured by Molloy Corp.. The device is a Class 1 Anesthesiology device with product code BSR cleared through the Traditional 510(k) pathway after a 659-day FDA review.

K943104 · Molloy Corp. · Anesthesiology device
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Apr 1996
Decision
659d
Days
Class 1
Risk

K943104 is an FDA 510(k) clearance for the MOLLOY INTUBATING STYLETTE. Classified as Stylet, Tracheal Tube (product code BSR), Class I - General Controls.

Submitted by Molloy Corp. (Lebanon, US). The FDA issued a Cleared decision on April 18, 1996 after a review of 659 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5790 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Molloy Corp. devices

FDA 510(k) Submission Details - K943104

510(k) Number K943104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1994
Decision Date April 18, 1996
Days to Decision 659 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
519d slower than avg
Panel avg: 140d · This submission: 659d
Pathway characteristics
Predicate-based equivalence.

BSR Device Classification - Class 1, General Controls

Product Code BSR Stylet, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5790
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSR Stylet, Tracheal Tube

All 17
Devices cleared under the same product code (BSR) and FDA review panel - the closest regulatory comparables to K943104.
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TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
K954771 · Laerdal Medical Corp. · May 1996
RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
K955238 · Rusch Intl. · Feb 1996
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AIRGUIDE STYLETTE
K950713 · Polamedco, Inc. · May 1995