Cleared Traditional

K812354 - KONTRON PMS 7000

K812354 is an FDA 510(k) clearance for KONTRON PMS 7000, manufactured by Kontron Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K812354 · Kontron Instruments, Inc. · Cardiovascular device
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Sep 1981
Decision
37d
Days
Class 2
Risk

K812354 is an FDA 510(k) clearance for the KONTRON PMS 7000. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Kontron Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 25, 1981 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kontron Instruments, Inc. devices

FDA 510(k) Submission Details - K812354

510(k) Number K812354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1981
Decision Date September 25, 1981
Days to Decision 37 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
88d faster than avg
Panel avg: 125d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 260
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K812354.
SIRECUST 425, RESPECTIVELY SIRECUST 430
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SPACELABS-GENERAL SYSTEM LINK
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MODEL IM1000 INTEGRATED MONITOR
K810731 · Gould, Inc. · Mar 1981
PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE
K810750 · General Electric Co. · Mar 1981
PACEMAKER PATIENT MGMT. SYSTEM
K801810 · Siemens Elema AB · Feb 1981