Cleared Traditional

K841148 - MINI PECG-MODIFICATION

K841148 is the FDA 510(k) clearance for MINI PECG-MODIFICATION by Intersect Systems, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K841148 · Intersect Systems, Inc. · Cardiovascular device
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Apr 1984
Decision
27d
Days
Class 2
Risk

K841148 is an FDA 510(k) clearance for the MINI PECG-MODIFICATION. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Intersect Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Intersect Systems, Inc. devices

Submission Details

510(k) Number K841148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1984
Decision Date April 17, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 254
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K841148.
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
MORTARA INSTRUMENT #101
K832050 · Mortara Instrument, Inc. · Dec 1983
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983