Cleared Traditional

K933278 - INTERMEDICS TRIANGLE CHEST PROBE MODEL ...

K933278 is an FDA 510(k) clearance for INTERMEDICS TRIANGLE CHEST PROBE MODEL ..., manufactured by Intermedics, Inc.. The device is a Class 3 Cardiovascular device with product code KRG cleared through the Traditional 510(k) pathway after a 624-day FDA review.

K933278 · Intermedics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
624d
Days
Class 3
Risk

K933278 is an FDA 510(k) clearance for the INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04. Classified as Programmer, Pacemaker (product code KRG), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on March 15, 1995 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3700 - 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. High regulatory complexity 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 Intermedics, Inc. devices

FDA 510(k) Submission Details - K933278

510(k) Number K933278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1993
Decision Date March 15, 1995
Days to Decision 624 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
499d slower than avg
Panel avg: 125d · This submission: 624d
Pathway characteristics
Predicate-based equivalence.

KRG Device Classification - Class 3, Premarket Approval

Product Code KRG Programmer, Pacemaker
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3700
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - KRG Programmer, Pacemaker

All 18
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K933278.
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K863046 · Cardiac Pacemakers, Inc. · Dec 1986
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K863045 · Cardiac Pacemakers, Inc. · Sep 1986
SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN
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