Cleared Traditional

K950989 - CARDIOSMART

K950989 is an FDA 510(k) clearance for CARDIOSMART, manufactured by Hellige GmbH. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 437-day FDA review.

K950989 · Hellige GmbH · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
437d
Days
Class 2
Risk

K950989 is an FDA 510(k) clearance for the CARDIOSMART. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Hellige GmbH (D7800 Freiburg Im Breisga, DE). The FDA issued a Cleared decision on May 13, 1996 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Hellige GmbH devices

FDA 510(k) Submission Details - K950989

510(k) Number K950989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1995
Decision Date May 13, 1996
Days to Decision 437 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
312d slower than avg
Panel avg: 125d · This submission: 437d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

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 403
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