Cleared Traditional

INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (K933278) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

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

Submission Details

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.

Device Classification

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 9
Devices cleared under the same product code (KRG) and FDA review panel - the closest regulatory comparables to K933278.
MODEL 2331T PATIENT PROGRAMMER
K880738 · Medtronic Vascular · Nov 1988
MODEL 1740 PERSONAL POCKET PROGRAMMER
K864712 · Telectronics, Inc. · Dec 1987
MODEL 5600B PROGRAMMER, PACEMAKER
K871986 · Telectronics, Inc. · Jun 1987
INTERMEDICS PROGRAMMER, MODEL 522-03
K812813 · Intermedics, Inc. · Oct 1981
CORDIS PACEMAKER PROGRAMMERS 255A & 256A
K810552 · Cordis Corp. · Mar 1981
OMNICOR PROGRAMMER MODEL 222C
K791419 · Cordis Corp. · Nov 1979