Cleared Traditional

K840398 - INLINE FOAM NOSE

K840398 is the FDA 510(k) clearance for INLINE FOAM NOSE by Mallinckrodt Critical Care. It is a Class 1 Anesthesiology device (product code BYD) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K840398 · Mallinckrodt Critical Care · Anesthesiology device
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Mar 1984
Decision
46d
Days
Class 1
Risk

K840398 is an FDA 510(k) clearance for the INLINE FOAM NOSE. Classified as Condenser, Heat And Moisture (artificial Nose) (product code BYD), Class I - General Controls.

Submitted by Mallinckrodt Critical Care (Walker, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 46 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 Critical Care devices

Submission Details

510(k) Number K840398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 1984
Decision Date March 16, 1984
Days to Decision 46 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
94d faster than avg
Panel avg: 140d · This submission: 46d
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 K840398.
SERVO HUMIDIFIER 153
K852601 · Siemens Elema AB · Jul 1985
SERVO HUMIDIFIER 152 SIEMENS-ELEMA AB
K844040 · Siemens Elema AB · Oct 1984
PALL HEAT MOISTURE EXCHANGING FILTER
K834292 · Pall Biomedical Products Co. · Apr 1984
FOAM NOSE
K840399 · Mallinckrodt Critical Care · Mar 1984
ENGSTOM EDITH
K821365 · Lkb Instruments, Inc. · Jun 1982
SIEMENS-ELEMA A.B. SERVO HUMIDIFIER 150
K790681 · Siemens Corp. · Apr 1979