Cleared Traditional

CARDIOLAB AMPLIFIER MODULE (CAM) (K910307) - FDA 510(k) Clearance

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

K910307 · Prucka Engineering, Inc. · Cardiovascular device
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Apr 1991
Decision
78d
Days
Class 2
Risk

K910307 is an FDA 510(k) clearance for the CARDIOLAB AMPLIFIER MODULE (CAM). Classified as Amplifier And Signal Conditioner, Biopotential (product code DRR), Class II - Special Controls.

Submitted by Prucka Engineering, Inc. (Houston, US). The FDA issued a Cleared decision on April 12, 1991 after a review of 78 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 Prucka Engineering, Inc. devices

Submission Details

510(k) Number K910307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1991
Decision Date April 12, 1991
Days to Decision 78 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 125d · This submission: 78d
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

Devices cleared under the same product code (DRR) and FDA review panel - the closest regulatory comparables to K910307.
BARD BIOPOTENTIAL AMPLIFIER
K874441 · C.R. Bard, Inc. · Jan 1988
HP MODEL 8880A FILTER
K802686 · Hewlett-Packard Co. · Nov 1980
MODEL 15055A MAINFRAME
K791964 · Hewlett-Packard Co. · Oct 1979
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