Cleared Traditional

K875322 - MODIFIED SCHNEIDER-SHILEY PRESSURE MANO...

K875322 is the FDA 510(k) clearance for MODIFIED SCHNEIDER-SHILEY PRESSURE MANO... by Schneider-Shilley (Usa). It is a Class 2 Cardiovascular device (product code KRK) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K875322 · Schneider-Shilley (Usa) · Cardiovascular device
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Mar 1988
Decision
90d
Days
Class 2
Risk

K875322 is an FDA 510(k) clearance for the MODIFIED SCHNEIDER-SHILEY PRESSURE MANOMETER. Classified as Manometer, Blood-pressure, Venous (product code KRK), Class II - Special Controls.

Submitted by Schneider-Shilley (Usa) (Minneapolis, US). The FDA issued a Cleared decision on March 28, 1988 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Schneider-Shilley (Usa) devices

Submission Details

510(k) Number K875322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1987
Decision Date March 28, 1988
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K875322.
UST-5268P-5 TRANSDUCER
K950607 · Aloka Co., Ltd. · Sep 1995
CENTRAL VENOUS PRESSURE MANOMETER
K904674 · Medex, Inc. · Dec 1990
SCHNEIDER-SHILEY PRESSURE MANOMETER
K861605 · Shiley, Inc. · May 1986
MEDIFIX
K813498 · Burron Medical Products, Inc. · Jan 1982
MEDIFIX GRADUATED SCALE
K813195 · Burron Medical Products, Inc. · Dec 1981