Cleared Traditional

K841246 - PORTABLE NURSING UNIT TERMINAL

K841246 is an FDA 510(k) clearance for PORTABLE NURSING UNIT TERMINAL, manufactured by Ncr Corp.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K841246 · Ncr Corp. · Cardiovascular device
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Nov 1984
Decision
230d
Days
Class 2
Risk

K841246 is an FDA 510(k) clearance for the PORTABLE NURSING UNIT TERMINAL. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Ncr Corp. (Ithaca, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 230 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 Ncr Corp. devices

FDA 510(k) Submission Details - K841246

510(k) Number K841246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1984
Decision Date November 08, 1984
Days to Decision 230 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 125d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 921
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