Cleared Traditional

K945513 - MALLINCKRODT SHILEY NEONATAL

K945513 is the FDA 510(k) clearance for MALLINCKRODT SHILEY NEONATAL by Mallinckrodt Medical. It is a Class 2 Anesthesiology device (product code JOH) cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K945513 · Mallinckrodt Medical · Anesthesiology device
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Jan 1995
Decision
65d
Days
Class 2
Risk

K945513 is an FDA 510(k) clearance for the MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on January 13, 1995 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mallinckrodt Medical devices

Submission Details

510(k) Number K945513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date January 13, 1995
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - JOH Tube Tracheostomy And Tube Cuff

All 59
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K945513.
MALLINCKRODT SHILEY 15MM CAP
K954749 · Mallinckrodt Medical · Jan 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955516 · Boston Medical Products, Inc. · Dec 1995
SUPERSLICK
K952700 · Bivona Medical Technologies · Oct 1995
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
SALINE SOLUTION-STERILE
K933412 · Trinity Laboratories, Inc. · Oct 1993
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993