Cleared Traditional

K980087 - PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330

K980087 is an FDA 510(k) clearance for PRESDURE PRODUCTS PRESSURE PADS, manufactured by Pressure Products, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K980087 · Pressure Products, Inc. · Cardiovascular device
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Jul 1998
Decision
173d
Days
Class 2
Risk

K980087 is an FDA 510(k) clearance for the PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210, P.... Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Pressure Products, Inc. (Rancho Palos Verdes, US). The FDA issued a Cleared decision on July 1, 1998 after a review of 173 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Pressure Products, Inc. devices

FDA 510(k) Submission Details - K980087

510(k) Number K980087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1998
Decision Date July 01, 1998
Days to Decision 173 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d slower than avg
Panel avg: 125d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 151
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K980087.
FLO-THRU
K981624 · Bio-Vascular, Inc. · Aug 1998
BALADI INVERTER WITH COAXIAL AORTIC PUNCH
K980128 · Cardio Medical Solutions, Inc. · Jul 1998
DEGANIA SILICONE IDENTI LOOPS
K981956 · Degania Silicone , Ltd. · Jul 1998
KOALA VASCULAR CLAMPS AND INSERTS
K980002 · Boss Instruments, Ltd. · Jun 1998
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
K980898 · Radi Medical Systems AB · Apr 1998