510(k) Report

510(k) · Cleared

Cleared

Stockert Power Supply Unit for S3 Components

K990512510(k) TraditionalCleared Nov 23, 1999278-day reviewClass I21 CFR 870.4200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Stoeckert Instrumente · KRI Accessory Equipment, Cardiopulmonary Bypass

Cleared on Nov 23, 1999 after a 278-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 23, 1999
Review
278 days
Class
Class I
Product code
KRI
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K990512Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KRI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KRI devices

KRI Accessory Equipment, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KRI

FDA has decided no KRI device since 2007.

Median 510(k) review, days · KRI

Too few KRI 510(k)s in any year since 2007 to give a median.

Recalls per year · KRI

2in 2011

2009: 32011: 2
2007high 3 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KRI

5in 2023

2014: 32016: 12021: 12022: 22023: 5
2007high 5 (2023) · low 0 (2007)2025

MAUDE reports naming product code KRI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—30
20100—00
20110—20
20120—00
20130—00
20140—03
20150—00
20160—01
20170—00
20180—00
20190—00
20200—00
20210—01
20220—02
20230—05
20240—00
20250—00
20260—0—

More from Stoeckert Instrumente

13 FDA decisions under this applicant name. See the company

  • K002273Stockert A272 Series Pediatric Aortic CannulaeStoeckert Instrumente · 2001
  • K001961Stockert A242 and A252 Series Arterial Femoral CannulaeStoeckert Instrumente · 2001
  • K002118Stockert Compact System Version 2.0Stoeckert Instrumente · 2000
  • K992635Interface Module IdddStoeckert Instrumente · 1999
  • K982014Stockert Compact SystemStoeckert Instrumente · 1998

Recent decisions in KRI

The KRI category page

  • K0203653TM Myocardial Needle-Temperature Probe3t Medical Systems, LLC · 2002
  • K992635Interface Module IdddStoeckert Instrumente · 1999
  • K934782Ammex Tubing OrganizerAmmex Cardiopulmonary Corp. · 1993
  • K926233CARDIO2 CycleErgometrix, Inc. · 1993
  • K922404Tube GripGeorgia Medical Products, Inc. · 1992

https://510kreport.com/device/K990512 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990512: Stockert Power Supply Unit for S3 Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990512

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026