Cleared Traditional

K941535 - TRACHEOLIFE

K941535 is the FDA 510(k) clearance for TRACHEOLIFE by Mallinckrodt Medical. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K941535 · Mallinckrodt Medical · Anesthesiology device

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Apr 1994

Decision

16d

Days

Class 1

Risk

K941535 is an FDA 510(k) clearance for the TRACHEOLIFE. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Mallinckrodt Medical (Argyle, US). The FDA issued a Cleared decision on April 15, 1994 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5375 - 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	K941535 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 30, 1994
Decision Date	April 15, 1994
Days to Decision	16 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

124d faster than avg

Panel avg: 140d · This submission: 16d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	BYD Condenser, Heat And Moisture (artificial Nose)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 868.5375

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 - BYD Condenser, Heat And Moisture (artificial Nose)

All 23

Devices cleared under the same product code (BYD) and FDA review panel - the closest regulatory comparables to K941535.

FILTER/HCH PRODUCT NUMBER 5710HEPA, 5710FILT

K950447 · Vital Signs, Inc. · Feb 1995

HYGROLIFE

K942794 · Mallinckrodt Medical · Aug 1994

HYGROSTER

K941585 · Mallinckrodt Medical · Apr 1994

HEPA FILTERED HEAT AND MOISTURE EXCHANGER

K935036 · Intertech Resources, Inc. · Jan 1994

VAPORTEMP HEAT AND MOISTURE EXCHANGER

K922946 · Mallinckrodt Medical · Mar 1993

5701, 5702, 5704, 5706 HYGROSCOPIC CONDENSER HUMID

K923865 · Vital Signs, Inc. · Feb 1993

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 K941535

Mallinckrodt Medical

Argyle, NY · US

FRANK STECIUK

Regulatory profile

43 submissions 42 cleared

98% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

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

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