Cleared Traditional

K982448 - CARDIOLIGHT

K982448 is an FDA 510(k) clearance for CARDIOLIGHT, manufactured by Capintec, Inc.. The device is a Class 2 Cardiovascular device with product code DSH cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K982448 · Capintec, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
331d
Days
Class 2
Risk

K982448 is an FDA 510(k) clearance for the CARDIOLIGHT. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on June 11, 1999 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K982448

510(k) Number K982448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1998
Decision Date June 11, 1999
Days to Decision 331 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 125d · This submission: 331d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSH Device Classification - Class 2, Special Controls

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 194
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K982448.
GLOBALCARDIO
K013354 · Cardiocomm Solutions, Inc. · Jan 2002
DR180+OXY
K004007 · North East Monitoring, Inc. · Jan 2001
LIFECARD CF COMPACT RECORDER
K001025 · Reynolds Medical , Ltd. · Apr 2000
OMNICORDER, MODEL 464
K990027 · Del Mar Avionics · Feb 1999
MERCATOR
K982384 · Harley Street Software , Ltd. · Jan 1999
MICROVIT MT-100
K973735 · Schiller America, Inc. · Aug 1998
K982448 · CARDIOLIGHT
Download PDF FDA Summary Capintec, Inc.