Cleared Traditional

K844187 - SIEMENS SIRECUST 404N NEONATAL MONITOR

K844187 is an FDA 510(k) clearance for SIEMENS SIRECUST 404N NEONATAL MONITOR, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K844187 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
164d
Days
Class 2
Risk

K844187 is an FDA 510(k) clearance for the SIEMENS SIRECUST 404N NEONATAL MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Englewood, US). The FDA issued a Cleared decision on April 11, 1985 after a review of 164 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 Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K844187

510(k) Number K844187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1984
Decision Date April 11, 1985
Days to Decision 164 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
39d slower than avg
Panel avg: 125d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

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 216
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K844187.
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985
KONTRON SUPERMON 7210 PATIENT MONITOR
K844731 · Kontron Instruments, Inc. · May 1985
HORIZON 1000 CARDIAC MONITOR
K850880 · Mennen Medical, Inc. · Apr 1985
KONTRON MINIMON 7134 PATIENT MONITOR
K844215 · Kontron Instruments, Inc. · Apr 1985
KONTRON MINIMON 7132 PATIENT MONITOR
K844732 · Kontron Instruments, Inc. · Mar 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · Kontron Instruments, Inc. · Mar 1985