Cleared Traditional

K861401 - LAERDAL POCKET MASK

K861401 is an FDA 510(k) clearance for LAERDAL POCKET MASK, manufactured by Laerdal Medical Corp.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K861401 · Laerdal Medical Corp. · Anesthesiology device
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May 1986
Decision
36d
Days
Class 2
Risk

K861401 is an FDA 510(k) clearance for the LAERDAL POCKET MASK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Laerdal Medical Corp. (Armonk, US). The FDA issued a Cleared decision on May 21, 1986 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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.

FDA 510(k) Submission Details - K861401

510(k) Number K861401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1986
Decision Date May 21, 1986
Days to Decision 36 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
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 102
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K861401.
INSPIRON(R) BREATH FOR LIFE EMERG. RESUSCITATOR
K870253 · Intertech Resources, Inc. · Mar 1987
DRV DISP RESUSCIT 3000/BAG ADAPT 3010 & 3011
K870382 · Nova-Ventrx · Mar 1987
PERSON TO PERSON VALVE-MASK & TRI-SEAL FACE MASK
K864472 · Tagg Industries · Jan 1987
RONDEX CPR VALVE
K855218 · Kondex Products, Inc. · Feb 1986
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
RESUSCITATION VALVE
K832868 · Boehringer Laboratories · Sep 1983
K861401 · LAERDAL POCKET MASK
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