Cleared Traditional

K853757 - MOLDTEC STIMULATOR

K853757 is an FDA 510(k) clearance for MOLDTEC STIMULATOR, manufactured by Moldtec, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 172-day FDA review.

K853757 · Moldtec, Inc. · Cardiovascular device
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Feb 1986
Decision
172d
Days
Class 2
Risk

K853757 is an FDA 510(k) clearance for the MOLDTEC STIMULATOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Moldtec, Inc. (New Orleans, US). The FDA issued a Cleared decision on February 28, 1986 after a review of 172 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 Moldtec, Inc. devices

FDA 510(k) Submission Details - K853757

510(k) Number K853757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1985
Decision Date February 28, 1986
Days to Decision 172 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 125d · This submission: 172d
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 228
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K853757.
PHYSIOLOGICAL TELEMETRY PATIENT MONITORING SYSTEM
K855125 · Honeywell, Inc. · Mar 1986
PATIENT MONITOR PB240
K853318 · Puritan Bennett Corp. · Mar 1986
SIRECUST 341 AND 341R
K854881 · Siemens Medical Solutions USA, Inc. · 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