Cleared Traditional

K880450 - RESUSCI PATIENT FACE SHIELD

K880450 is an FDA 510(k) clearance for RESUSCI PATIENT FACE SHIELD, manufactured by Laerdal Medical Corp.. The device is a Class 2 Anesthesiology device with product code BTM cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K880450 · Laerdal Medical Corp. · Anesthesiology device
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Mar 1988
Decision
31d
Days
Class 2
Risk

K880450 is an FDA 510(k) clearance for the RESUSCI PATIENT FACE SHIELD. Classified as Ventilator, Emergency, Manual (resuscitator) (product code BTM), Class II - Special Controls.

Submitted by Laerdal Medical Corp. (Armonk, US). The FDA issued a Cleared decision on March 4, 1988 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5915 - 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 - K880450

510(k) Number K880450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date March 04, 1988
Days to Decision 31 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
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTM Device Classification - Class 2, Special Controls

Product Code BTM Ventilator, Emergency, Manual (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5915
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 - BTM Ventilator, Emergency, Manual (resuscitator)

All 207
Devices cleared under the same product code (BTM) and FDA review panel - the closest regulatory comparables to K880450.
RESUSCITATION BAG CONTROLLER (RBC)
K882278 · Physician Engineered Products, Inc. · Jun 1988
LIFEGUARD MOUTH TO MASK RESUSCITATOR
K881086 · Lifeguard Medical Products, Inc. · Apr 1988
LIFEGUARD SINGLE USE MANUAL RESUSCITATORS
K881087 · Lifeguard Medical Products, Inc. · Apr 1988
RESUSCITATOR
K874567 · American Medical Technology, Inc. · Feb 1988
FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
K880394 · Intertech/Ohio · Feb 1988
LSP DISPOSABLE BAG RESUSCITATOR, MODEL 470
K874418 · Life Support Products, Inc. · Jan 1988
K880450 · RESUSCI PATIENT FACE SHIELD
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