Cleared Traditional

K873461 - LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)

K873461 is the FDA 510(k) clearance for LASER-FLEX(TM) TRACHEAL TUBE (CUFFED) by Mallinckrodt Critical Care. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K873461 · Mallinckrodt Critical Care · Anesthesiology device

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Nov 1987

Decision

70d

Days

Class 2

Risk

K873461 is an FDA 510(k) clearance for the LASER-FLEX(TM) TRACHEAL TUBE (CUFFED). Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on November 6, 1987 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Critical Care devices

Submission Details

510(k) Number	K873461 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 1987
Decision Date	November 06, 1987
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

70d faster than avg

Panel avg: 140d · This submission: 70d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTR Tube, Tracheal (w/wo Connector)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5730

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 - BTR Tube, Tracheal (w/wo Connector)

All 117

Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K873461.

MONTGOMERY(R) TAPERED SAFE-T-TUBE(TM)

K903876 · Boston Medical Products, Inc. · Feb 1991

KENDALL CURITY ENDOTRACHEAL TUBES

K892432 · The Kendal Co. · Jun 1989

NDYAG LASER TRACHEAL TUBE

K880960 · Sheridan Catheter Corp. · Apr 1988

AIRE-CUF POLYESTER RE-ENFORCED ENDOTRACHEAL TUBE

K872366 · Bivona Medical Technologies · Aug 1987

BELL/MCKAY TRACHEAL TUBE

K872616 · Sheridan Catheter Corp. · Aug 1987

EUROMEDICAL, ENDOSOFT ENDOTRACHEAL TUBE

K870387 · American Pharmaseal Div. Ahsc · May 1987

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K873461

Mallinckrodt Critical Care

Argyle, NY · US

E WIEGERT,PHD

Regulatory profile

92 submissions 92 cleared

100% clearance rate · Active in Anesthesiology

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Sourced from FDA 510(k) public files . Updated monthly.

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