Cleared Traditional

K831698 - DISPOSABLE PRESSURE TRANSDUCER#14004195

K831698 is the FDA 510(k) clearance for DISPOSABLE PRESSURE TRANSDUCER#14004195 by Norton Performance Plastics Corp.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K831698 · Norton Performance Plastics Corp. · Cardiovascular device
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Aug 1983
Decision
78d
Days
Class 2
Risk

K831698 is an FDA 510(k) clearance for the DISPOSABLE PRESSURE TRANSDUCER#14004195. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Norton Performance Plastics Corp. devices

Submission Details

510(k) Number K831698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 1983
Decision Date August 11, 1983
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 70
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K831698.
TRANSDUCER DOME SD105
K833095 · Sorensen Research · Nov 1983
TRANSDUCER DOME DS106
K833096 · Sorensen Research · Nov 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · Sorensen Research · Aug 1983
DISPOSABLE PRESSURE TRANSDUCER
K830210 · American Pharmaseal Div. Ahsc · Apr 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
DISPOSABLE TRANSDUCER DOMES & KITS
K821894 · American Pharmaseal Div. Ahsc · Jul 1982