Cleared Traditional

K990512 - STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS

K990512 is an FDA 510(k) clearance for STOCKERT POWER SUPPLY UNIT FOR S3 COMPO..., manufactured by Stoeckert Instrumente. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K990512 · Stoeckert Instrumente · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
278d
Days
Class 1
Risk

K990512 is an FDA 510(k) clearance for the STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Stoeckert Instrumente (North Attleboro, US). The FDA issued a Cleared decision on November 23, 1999 after a review of 278 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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 Stoeckert Instrumente devices

FDA 510(k) Submission Details - K990512

510(k) Number K990512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1999
Decision Date November 23, 1999
Days to Decision 278 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 125d · This submission: 278d
Pathway characteristics
Predicate-based equivalence.

KRI Device Classification - Class 1, General Controls

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

All 32
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K990512.
INTERFACE MODULE IDDD
K992635 · Stoeckert Instrumente · Dec 1999
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25
K884893 · American Omni Medical, Inc. · Jan 1989
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700
K884640 · American Omni Medical, Inc. · Jan 1989
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR
K874605 · Mallinckrodt Critical Care · Feb 1988
CPE 2000 CARDIO PULMONARY ERGOMETER
K874925 · Medical Graphics Corp. · Jan 1988
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP
K864890 · Shiley, Inc. · Feb 1987