Cleared Traditional

K860646 - PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART

K860646 is an FDA 510(k) clearance for PATIENT MON 1280/1281/120C/121C & MULTI..., manufactured by Analogic Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K860646 · Analogic Corp. · Cardiovascular device
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Oct 1986
Decision
238d
Days
Class 2
Risk

K860646 is an FDA 510(k) clearance for the PATIENT MON 1280/1281/120C/121C & MULTI-PARA CART. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on October 16, 1986 after a review of 238 days - an extended review cycle.

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 Analogic Corp. devices

FDA 510(k) Submission Details - K860646

510(k) Number K860646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date October 16, 1986
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
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 417
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K860646.
630C ELECTROCARDIOGRAPH
K863030 · Quinton, Inc. · Nov 1986
ECG MODULE
K862553 · Elscint, Inc. · Nov 1986
SERIES 7200 TRANSPORT/REMOTE ACQUISITION MONITOR
K860734 · Marquette Electronics, Inc. · Nov 1986
SPACELABS SERIES 90700 PATIENT MONITORS
K862951 · Spacelabs, Inc. · Sep 1986
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · Nihon Kohden America, Inc. · Sep 1986
BURDICK DIVISION (E-500)
K861850 · Mortara Instrument, Inc. · Aug 1986