Cleared Traditional

K892890 - STETH-SHIELD(TM)

K892890 is an FDA 510(k) clearance for STETH-SHIELD(TM), manufactured by North East Technology. The device is a Class 2 Cardiovascular device with product code DQD cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K892890 · North East Technology · Cardiovascular device
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Dec 1989
Decision
225d
Days
Class 2
Risk

K892890 is an FDA 510(k) clearance for the STETH-SHIELD(TM). Classified as Stethoscope, Electronic (product code DQD), Class II - Special Controls.

Submitted by North East Technology (Geneva On The Lake, US). The FDA issued a Cleared decision on December 1, 1989 after a review of 225 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1875 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all North East Technology devices

FDA 510(k) Submission Details - K892890

510(k) Number K892890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date December 01, 1989
Days to Decision 225 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 125d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQD Device Classification - Class 2, Special Controls

Product Code DQD Stethoscope, Electronic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1875
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 - DQD Stethoscope, Electronic

All 114
Devices cleared under the same product code (DQD) and FDA review panel - the closest regulatory comparables to K892890.
LABTRON ELECTROMAX ELECTRONIC STETHOSCOPE MODEL NO. 04-1060
K961857 · Graham-Field, Inc. · Jul 1996
E-SCOPE ELECTRONIC STETHOSCOPE MODEL 718-7120
K961301 · Delphi Consulting Group · Jun 1996
3M LITTMANN GRAPHIC DISPLAY SYSTEM
K920009 · 3M Health Care, Ltd. · Oct 1992
MASCOT STETHOSCOPE PROBE
K874726 · Imex Medical Systems, Inc. · Mar 1988
DIF-STET
K832882 · Intersect Systems, Inc. · Dec 1983
CONPHAR SUPERTONE STETHOSCOPE
K801189 · Conphar, Inc. · Jun 1980