Cleared Traditional

K984033 - ATLAS MONITOR

K984033 is the FDA 510(k) clearance for ATLAS MONITOR by Welch Allyn, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K984033 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
238d
Days
Class 2
Risk

K984033 is an FDA 510(k) clearance for the ATLAS MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 8, 1999 after a review of 238 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Welch Allyn, Inc. devices

Submission Details

510(k) Number K984033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1998
Decision Date July 08, 1999
Days to Decision 238 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
113d slower than avg
Panel avg: 125d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 142
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K984033.
PM-8000 PATIENT MONITOR, MODEL 8000
K032733 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2004
SIEMENS INFINITY SC 6002XL MODIFICATIONS
K020144 · Siemens Medical Solutions USA, Inc. · Feb 2002
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM
K012763 · Cobe Cardiovascular, Inc. · Nov 2001
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · Datascope Corp. · Jun 1998
NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES
K973918 · Nihon Kohden America, Inc. · Jan 1998
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M850-P
K972787 · Alexander Mfg. Co. · Oct 1997