Cleared Traditional

K950607 - UST-5268P-5 TRANSDUCER

K950607 is an FDA 510(k) clearance for UST-5268P-5 TRANSDUCER, manufactured by Aloka Co., Ltd.. The device is a Class 2 Radiology device with product code KRK cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K950607 · Aloka Co., Ltd. · Radiology device
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Sep 1995
Decision
218d
Days
Class 2
Risk

K950607 is an FDA 510(k) clearance for the UST-5268P-5 TRANSDUCER. Classified as Manometer, Blood-pressure, Venous (product code KRK), Class II - Special Controls.

Submitted by Aloka Co., Ltd. (Wallingford, US). The FDA issued a Cleared decision on September 15, 1995 after a review of 218 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.1140 - the FDA radiology and imaging software 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Aloka Co., Ltd. devices

FDA 510(k) Submission Details - K950607

510(k) Number K950607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1995
Decision Date September 15, 1995
Days to Decision 218 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 107d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRK Device Classification - Class 2, Special Controls

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 Radiology 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 K950607.
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · Medex, Inc. · Dec 1990
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · Shiley, Inc. · May 1986
MANOMETER SET C.V.P. #S 298/299
K830910 · Exco, Inc. · Apr 1983
MEDIFIX
K813498 · Burron Medical Products, Inc. · Jan 1982
MEDIFIX GRADUATED SCALE
K813195 · Burron Medical Products, Inc. · Dec 1981