Cleared Traditional

ECG AMPLIFIER/R WAVE TRIGGER (K771976) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K771976 · G.D. Searle and Co. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1977
Decision
23d
Days
Class 2
Risk

K771976 is an FDA 510(k) clearance for the ECG AMPLIFIER/R WAVE TRIGGER. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by G.D. Searle and Co. (Mchenry, US). The FDA issued a Cleared decision on November 9, 1977 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 870.2050 - the FDA radiology and imaging software 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all G.D. Searle and Co. devices

Submission Details

510(k) Number K771976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1977
Decision Date November 09, 1977
Days to Decision 23 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 107d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRR Amplifier And Signal Conditioner, Biopotential
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2050
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 Radiology devices follow this clearance model.

Regulatory Peers - DRR Amplifier And Signal Conditioner, Biopotential

All 8
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K771976.
MODEL 15055A MAINFRAME
K791964 · Hewlett-Packard Co. · Oct 1979
ESIS MODULE
K780043 · Datascope Corp. · Feb 1978
AMPLIFIER MODULE, 78211A ECG
K772132 · Hewlett-Packard Co. · Nov 1977
PATIENT MONITORS MODELS 78701A/78702A
K771572 · Hewlett-Packard Co. · Aug 1977
DISPLAY MONITOR (MODEL 78301A)
K761056 · Hewlett-Packard Co. · Dec 1976