Cleared Traditional

K874415 - PRESSURE LIMIT CONTROL

K874415 is an FDA 510(k) clearance for PRESSURE LIMIT CONTROL, manufactured by Draeger Medical, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K874415 · Draeger Medical, Inc. · Anesthesiology device
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Jan 1988
Decision
75d
Days
Class 2
Risk

K874415 is an FDA 510(k) clearance for the PRESSURE LIMIT CONTROL. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Draeger Medical, Inc. (Telford, US). The FDA issued a Cleared decision on January 11, 1988 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Draeger Medical, Inc. devices

FDA 510(k) Submission Details - K874415

510(k) Number K874415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1987
Decision Date January 11, 1988
Days to Decision 75 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
65d faster than avg
Panel avg: 140d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K874415.
GAMBRO-ENGSTROM ERICA IV RESPIRATOR
K872482 · Gambro, Inc. · Mar 1988
COMPANION 2800A PORTABLE VENTILATOR - MODIFICATION
K873215 · Puritan Bennett Corp. · Jan 1988
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · Impact Instrumentation, Inc. · Jan 1988
ASCENDING VENTILATOR BELLOWS
K874371 · Draeger Medical, Inc. · Dec 1987
PEDIATRIC BELLOWS
K873549 · Draeger Medical, Inc. · Oct 1987
SERVO VENTILATOR 900 C/D
K871354 · Siemens Elema AB · Jul 1987