510(k) Report

510(k) · Cleared

Cleared

Siemens Infinity SC 6002XL Enhanced with ST Segment Analysis

K002105510(k) TraditionalCleared Dec 5, 2000146-day reviewClass II21 CFR 870.1025

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

Siemens Medical Solutions USA, Inc. · MLD Monitor, St Segment With Alarm

Cleared on Dec 5, 2000 after a 146-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Dec 5, 2000
Review
146 days
Class
Class II
Product code
MLD
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared200020052010201520202025
  1. This deviceK002105 Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc. · 2000
  2. Descendant · cites it directly · 0 of its ownK020144 Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc. · 2002

Most influential descendants

Showing 1 of 1 · See all
  • K020144Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002105Siemens Infinity SC 6002XL Enhanced with ST Segment AnalysisSiemens Medical Solutions USA, Inc.2000—
+1K020144Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K002105, 2000–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 MLD? 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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020144Siemens Infinity SC 6002XL ModificationsSiemens Medical Solutions USA, Inc.20020

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.

What does this lineage say?

  • Of its descendants, K020144 (Siemens Medical Solutions USA, Inc., 2002) has gone furthest, with 0 descendants of its own.

How does its category compare?

All MLD devices

MLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MLD

1in 2010

2008: 12010: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MLD

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

Recalls per year · MLD

No recall names MLD since 2007.

Adverse event reports per year · MLD

1in 2019

2007: 32008: 52009: 32010: 32011: 62012: 72014: 12015: 12017: 12018: 12019: 1
2007high 7 (2012) · low 0 (2013)2025

MAUDE reports naming product code MLD, 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—03
20081—05
20090—03
20101—03
20110—06
20120—07
20130—00
20140—01
20150—01
20160—00
20170—01
20180—01
20190—01
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

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Recent decisions in MLD

The MLD category page

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https://510kreport.com/device/K002105 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002105: Siemens Infinity SC 6002XL Enhanced with ST Segment Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002105

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