Cleared Traditional

K021520 - EMT-CPAP

K021520 is an FDA 510(k) clearance for EMT-CPAP, manufactured by Emergency Medical Techology. The device is a Class 2 Anesthesiology device with product code BTL cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K021520 · Emergency Medical Techology · Anesthesiology device
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Jul 2002
Decision
66d
Days
Class 2
Risk

K021520 is an FDA 510(k) clearance for the EMT-CPAP. Classified as Ventilator, Emergency, Powered (resuscitator) (product code BTL), Class II - Special Controls.

Submitted by Emergency Medical Techology (Irvine, US). The FDA issued a Cleared decision on July 15, 2002 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5925 - 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 Emergency Medical Techology devices

FDA 510(k) Submission Details - K021520

510(k) Number K021520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date July 15, 2002
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTL Device Classification - Class 2, Special Controls

Product Code BTL Ventilator, Emergency, Powered (resuscitator)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5925
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 - BTL Ventilator, Emergency, Powered (resuscitator)

All 64
Devices cleared under the same product code (BTL) and FDA review panel - the closest regulatory comparables to K021520.
PARAPAC 200D TRANSPORT, MODEL V200D
K030803 · Pneupac , Ltd. · Sep 2003
COMPPAC VENTILATOR MODELS 200 & PS11 POWER SUPPLY/CHARGER
K021841 · Pneupac , Ltd. · Jul 2003
PARAPAC 200 MEDIC, MODEL P200, & PARAPAC 200D MEDIC, MODEL P200D
K020899 · Pneupac , Ltd. · Dec 2002
RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
K001430 · Vortran Medical Technology 1, Inc. · Jul 2000
MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR
K991785 · Instrumentation Industries, Inc. · Aug 1999
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195 · O-Two Systems Intl., Inc. · Apr 1999