510(k) · Cleared
ClearedPcecg-1200 System with Modular Ecg Analysis System (Means)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norav Medical, Ltd. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Nov 10, 2011 as substantially equivalent to K080141 (Norav Medical, Ltd., 2008) after a 266-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Nov 10, 2011
- Review
- 266 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000404 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 MWI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080141 | PC Ecg 1200W SystemSummary page 1…870.2920 Classification code 2 DXH Substantial Equivalence 21 CFR BO7.92(aX3l 1. Norav's PC EVG 120OW System k080 141 for omiplete physical and functional identity 2. Welch Allyn's GardloPerfect Workstation (CPWS) V 1.6.2 Software k08i3247* (devel… | 2008 |
| Kept off the family tree | K081324 | FDA’s K081324 is Candela Family of Q-Switched Alexandrite Lasers Our reading of the summary gave K081324, FDA’s number for Candela Family of Q-Switched Alexandrite Lasers (Candela Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Welch Allyn's CardioPerfect Workstation (CPWS) V 1.6.2 Software”. Kept off the family tree. | 2008 |
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?
- The line of descent spans 11 years and passes through 1 company; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K080141.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
ECG intended use: ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia, rate abnormalities, or features of prognostic value in patients: 1) suspected of cardiac abnormalities, or 2) in populations of patients at an age or period in which a routine baseline evaluation of EG characteristics are desired. 3) QT Analysis is useful in the assessment of long QT syndrome (LOTS). In some instances, LQTS can be…
Read the full statement (391 words)
ECG intended use:
ECG is intended to disclose either normal condition or patterns of arrhythmia, myocardial ischemia,
rate abnormalities, or features of prognostic value in patients:
1) suspected of cardiac abnormalities, or
2) in populations of patients at an age or period in which a routine baseline evaluation of EG
characteristics are desired.
3) QT Analysis is useful in the assessment of long QT syndrome (LOTS). In some instances, LQTS
can be corrected by pharmacologic therapy. QT analysis is also used to measure QT dispersion, the
difference between maximal and minimal QT values. QT dispersion is a measure of the
inhomogeneity of ventricular repolarization.
4) The PCECG-1200 System With MEANS has been tested to measure Heart Rate Variability within 1
millisecond tolerance. The clinical significance of HRV measures should be determined by a physician.
5) The PCECG-1200 System With MEANS has been tested to measure Late Potential within 1
millisecond tolerance in the time domain, and 1 microvolt tolerance in voltage. The clinical significance of
Heart Rate Variability measures should be determined by a physician.
Stress testing intended use:
Angina pectoris (chest pain) is a clinical syndrome resulting from myocardial ischemnia, indicative of a
reduced blood supply to the cardiac muscle. The electrocardiogram may establish the diagnosis of
ischemic heart disease if characteristic changes are present. Stress testing is the most widely used
method to decide whether this chest pain is related to myocardial ischemia, and thereby coronary
artery disease. Instress testing, the contractile capability of the heart muscle is monitored via ECG
during patient exercise. Patients are exercised by bicycle, treadmill, or other means while
continuously monitoring the EGG. Exercise loads are determined by predefined protocols. The EG
signals are recorded for the resting, exercise and recovery portions of the exercise protocol. The
changes in EGG waveforms are compared to the resting ECG records. Although not necessary, most
of the commercial stress test systems control the bicycle or treadmill automatically according to the
requirements of the chosen protocol.
ST segment monitoring is intended as an aid in the evaluation of myocardial ischemnia in patients with
known or suspected coronary artery disease. The ST segment algorithm has been tested for
accuracy of the ST segment data, and a database has been used as a tool for performance testing.
The significance of the ST segment changes must be determined by a physician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110463 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110463: Pcecg-1200 System with Modular Ecg Analysis System (Means).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110463
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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