Cleared Traditional

K854881 - SIRECUST 341 AND 341R

K854881 is an FDA 510(k) clearance for SIRECUST 341 AND 341R, 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 95-day FDA review.

K854881 · Siemens Medical Solutions USA, Inc. · Cardiovascular device
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Mar 1986
Decision
95d
Days
Class 2
Risk

K854881 is an FDA 510(k) clearance for the SIRECUST 341 AND 341R. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 11, 1986 after a review of 95 days - within the typical 510(k) review window.

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 - K854881

510(k) Number K854881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1985
Decision Date March 11, 1986
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
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 K854881.
CARDIOCAP MONITOR
K853953 · Instrumentarium Corp. · Jun 1986
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · Honeywell, Inc. · Mar 1986
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986
ECS 502
K840717 · Robert Bosch Corp. · Aug 1985
VSM MODELS A & B
K851916 · Physio-Control Corp. · Aug 1985
MODEL 78353B
K842817 · Hewlett-Packard Co. · Jun 1985