Cleared Traditional

K895520 - PAGEWRITER XLI M1700A & PAGEWRITER XL M...

K895520 · Hewlett-Packard Co. · Cardiovascular device
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Jul 1990
Decision
308d
Days
-
Risk

K895520 is an FDA 510(k) clearance for the PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A.

Submitted by Hewlett-Packard Co. (Mcminnville, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K895520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date July 17, 1990
Days to Decision 308 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
183d slower than avg
Panel avg: 125d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 43
Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K895520.
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ELITE II ELECTROCARDIOGRAPH
K904032 · Burdick Corp. · Jul 1991
MODEL ELI-100/ST ELECTROCARDIOGRAPH
K895232 · Mortara Instrument, Inc. · Dec 1989
SPACELABS MODEL 90900
K894093 · Spacelabs, Inc. · Nov 1989
FUKUDA DENSHI MODEL FCP-2201
K892796 · Fukuda Denshi USA, Inc. · Oct 1989