Cleared Traditional

K884386 - ADMINISTRATION/MANOMETER SET W/3 WAY ST...

K884386 is the FDA 510(k) clearance for ADMINISTRATION/MANOMETER SET W/3 WAY ST... by Ethitek Pharmaceuticals Co.. It is a Class 2 Cardiovascular device (product code KRK) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K884386 · Ethitek Pharmaceuticals Co. · Cardiovascular device
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Jan 1989
Decision
79d
Days
Class 2
Risk

K884386 is an FDA 510(k) clearance for the ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK. Classified as Manometer, Blood-pressure, Venous (product code KRK), Class II - Special Controls.

Submitted by Ethitek Pharmaceuticals Co. (Skokie, US). The FDA issued a Cleared decision on January 5, 1989 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1140 - the FDA cardiovascular device oversight 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 Ethitek Pharmaceuticals Co. devices

Submission Details

510(k) Number K884386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date January 05, 1989
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRK Manometer, Blood-pressure, Venous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1140
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - KRK Manometer, Blood-pressure, Venous

Devices cleared under the same product code (KRK) and FDA review panel - the closest regulatory comparables to K884386.
UST-5268P-5 TRANSDUCER
K950607 · Aloka Co., Ltd. · Sep 1995
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K813498 · Burron Medical Products, Inc. · Jan 1982
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K813195 · Burron Medical Products, Inc. · Dec 1981