Cleared Traditional

K841611 - QUINTON 901 & 900 HOLTER SCANNER

K841611 is an FDA 510(k) clearance for QUINTON 901 & 900 HOLTER SCANNER, manufactured by Quinton, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K841611 · Quinton, Inc. · Cardiovascular device
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Aug 1984
Decision
121d
Days
Class 2
Risk

K841611 is an FDA 510(k) clearance for the QUINTON 901 & 900 HOLTER SCANNER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Quinton, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 2, 1984 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Quinton, Inc. devices

FDA 510(k) Submission Details - K841611

510(k) Number K841611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1984
Decision Date August 02, 1984
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 429
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K841611.
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FITNESS LOGGER
K840020 · Britt Corp., Inc. · Oct 1984
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN
K833593 · Brentwood Instruments, Inc. · May 1984
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984
MINI PECG-MODIFICATION
K841148 · Intersect Systems, Inc. · Apr 1984