510(k) · Cleared
ClearedSiemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MLD Monitor, St Segment With Alarm
Cleared on Feb 26, 1998 as substantially equivalent to K951371 (Siemens Medical Solutions USA, Inc., 1995) after a 90-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Feb 26, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- MLD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K951371 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK951371 1481 T Digital Telemetry System with S-T Segment Analysis OptionSiemens Medical Solutions USA, Inc. · 1995
- This deviceK974492 Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST…Siemens Medical Solutions USA, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K951371 | 1481 T Digital Telemetry System with S-T Segment Analysis Option | Siemens Medical Solutions USA, Inc. | 1995 | — |
| 0 (this device) | K974492 | Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment… | Siemens Medical Solutions USA, Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K951371 | 1481 T Digital Telemetry System with S-T Segment Analysis OptionSummary page 1…LD m 21 CFR 870.1025 Arthythmia Detector & Alarm Systerm 74DST Il | 21 CFR 870.1025 Identi The Siemens 1481 (T) Digital Telemetry System with ST Segment Analysis Option (K951371) COMPANY CONFIDENTIAL Siemens Medical Systems, Inc. Electromedical Systems Group, PCS 16 Elecuonics Avenue Tel: (978) 907-7500 D… | 1995 |
| † | K944350 | SC 6000/ SC 6000P/ R50 | 1995 |
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.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K951371.
How does its category compare?
All MLD devicesMLD Monitor, St Segment With Alarm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLD
1in 2010
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
MAUDE reports naming product code MLD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SC6000/SC6000P enhanced with ST Segment Analysis is intended to be used in the environment where patient care is provided by Healthcare Professionals, trained in the use of the device, i.e. physicians, nurses, and technicians, who will determine when use of ST Segment Analysis is indicated, based upon their professional assessment of the patient's medical condition.
ST Segment Analysis is intended for use in the adult population.
The SC6000/SC6000P is not for home use.
The Siemens SC6000 / SC6000P Bedside Monitoring System is not compatible for use in a MRI magnetic field.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974492 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974492: Siemens SC6000/SC6000P Bedside Monitoring System Enhanced with ST Segment Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974492
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026