Cleared Traditional

Q750 ELECTROCARDIOGRAPH (K885000) - FDA 510(k) Clearance

K885000 · Quinton, Inc. · Cardiovascular device

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Feb 1989

Decision

84d

Days

Risk

K885000 is an FDA 510(k) clearance for the Q750 ELECTROCARDIOGRAPH.

Submitted by Quinton, Inc. (Seattle, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 84 days - a notably fast clearance cycle.

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: 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 Quinton, Inc. devices

Submission Details

510(k) Number	K885000 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 01, 1988
Decision Date	February 23, 1989
Days to Decision	84 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

41d faster than avg

Panel avg: 125d · This submission: 84d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LOS
Device Class	-

Regulatory Peers - LOS

All 14

Devices cleared under the same product code (LOS) and FDA review panel - the closest regulatory comparables to K885000.

HP M177XA CARDIOGRAPHS

K935772 · Hewlett-Packard Co. · Jul 1994

CARDIOFAX Q ECG-8420A

K922394 · Nihon Kohden America, Inc. · Mar 1994

PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A

K895520 · Hewlett-Packard Co. · Jul 1990

MINGOGRAF 740 - MODEL #91-54-634

K864575 · Siemens Medical Solutions USA, Inc. · May 1987

N-CHANNEL

K834212 · Philips Medical Systems (Cleveland), Inc. · Nov 1984

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K885000

Quinton, Inc.

Seattle, WA · US

RON R DUCK

Regulatory profile

164 submissions 160 cleared

98% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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