Cleared Traditional

K961247 - AS/3 LIGHT MONITOR

K961247 is an FDA 510(k) clearance for AS/3 LIGHT MONITOR, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K961247 · Datex Division Instrumentarium Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
205d
Days
Class 2
Risk

K961247 is an FDA 510(k) clearance for the AS/3 LIGHT MONITOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Tewksbury, US). The FDA issued a Cleared decision on October 23, 1996 after a review of 205 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K961247

510(k) Number K961247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date October 23, 1996
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
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 326
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K961247.
POSEIDON CARDIAC MONITORING SYSTEM (PCMS)
K964408 · Instromedix, Inc. · Jul 1997
ALEXANDER MFG. RECHARGEABLE BATTERY (MODEL M3)
K970787 · Alexander Mfg. Co. · May 1997
NELLCOR SYMPHONY N-3000 PATIENT MONITOR WITH SPO2 AND ECG AND N-3200 DISPLAY/PRINTER
K963400 · Nellcor Puritan Bennett, Inc. · Nov 1996
HP CATHSTATION - MODEL M1264B
K961401 · Hewlett-Packard Co. · Oct 1996
PATIENT MONITOR MODEL 405P
K955546 · Ivy Biomedical Systems, Inc. · Aug 1996
DINAMAP SELECT MULTI-PARAMETER SYSTEM
K955113 · Johnson & Johnson Medical, Inc. · Aug 1996