Cleared Traditional

K772132 - AMPLIFIER MODULE

K772132 is the FDA 510(k) clearance for AMPLIFIER MODULE by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DRR) cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K772132 · Hewlett-Packard Co. · Cardiovascular device
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Nov 1977
Decision
8d
Days
Class 2
Risk

K772132 is an FDA 510(k) clearance for the AMPLIFIER MODULE, 78211A ECG. Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1977 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2050 - 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: 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K772132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1977
Decision Date November 22, 1977
Days to Decision 8 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 125d · This submission: 8d
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DRR Amplifier And Signal Conditioner, Biopotential

All 11
Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K772132.
HP MODEL 8880A FILTER
K802686 · Hewlett-Packard Co. · Nov 1980
MODEL 15055A MAINFRAME
K791964 · Hewlett-Packard Co. · Oct 1979
ESIS MODULE
K780043 · Datascope Corp. · Feb 1978
ECG AMPLIFIER/R WAVE TRIGGER
K771976 · G.D. Searle and Co. · Nov 1977
PATIENT MONITORS MODELS 78701A/78702A
K771572 · Hewlett-Packard Co. · Aug 1977
ELGILOY STYLET
K770243 · Cardiac Pacemakers, Inc. · Feb 1977