Cleared Traditional

K844187 - SIEMENS SIRECUST 404N NEONATAL MONITOR

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

K844187 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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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

Submission Details

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.

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 147
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K844187.
MODEL 78353B
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K844732 · Kontron Instruments, Inc. · Mar 1985
KONTRON MINIMON 7131 PATIENT MONITOR
K844733 · Kontron Instruments, Inc. · Mar 1985