Cleared Traditional

K915757 - MODELS M1722A

K915757 is the FDA 510(k) clearance for MODELS M1722A by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DRO) cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K915757 · Hewlett-Packard Co. · Cardiovascular device
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Jul 1992
Decision
220d
Days
Class 2
Risk

K915757 is an FDA 510(k) clearance for the MODELS M1722A, M1723A, M1724A DEFIBRILLATORS. Classified as Pacemaker, Cardiac, External Transcutaneous (non-invasive) (product code DRO), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 220 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5550 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K915757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date July 30, 1992
Days to Decision 220 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 125d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5550
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 - DRO Pacemaker, Cardiac, External Transcutaneous (non-invasive)

All 19
Devices cleared under the same product code (DRO) and FDA review panel - the closest regulatory comparables to K915757.
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K894492 · Nihon Kohden America, Inc. · Dec 1989
DEFIB/PACING PADS
K894588 · Conmedcorp · Oct 1989