Cleared Traditional

K851614 - CENTRIMED SYSTEM 1 W/24 VOLT BATTERY PO...

K851614 is the FDA 510(k) clearance for CENTRIMED SYSTEM 1 W/24 VOLT BATTERY PO... by Centrimed Corp.. It is a Class 2 Cardiovascular device (product code DTQ) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K851614 · Centrimed Corp. · Cardiovascular device
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Jun 1985
Decision
61d
Days
Class 2
Risk

K851614 is an FDA 510(k) clearance for the CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Centrimed Corp. (Hopkins, US). The FDA issued a Cleared decision on June 19, 1985 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Centrimed Corp. devices

Submission Details

510(k) Number K851614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1985
Decision Date June 19, 1985
Days to Decision 61 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 125d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 19
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K851614.
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