510(k) · Cleared
ClearedNorav Holter System, Model NH-300 V1.07
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norav Medical, Ltd. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on May 8, 2002 after a 267-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 8, 2002
- Review
- 267 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012712 Norav Holter System, Model NH-300 V1.07Norav Medical, Ltd. · 2002
- Descendant · cites it directly · 0 of its ownK111487 NH-301 Ambulatory Ecg Analysis SoftwareNorav Medical Corp. · 2011
Most influential descendants
Showing 1 of 1 · See all- K111487NH-301 Ambulatory Ecg Analysis SoftwareNorav Medical Corp. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012712 | Norav Holter System, Model NH-300 V1.07 | Norav Medical, Ltd. | 2002 | — |
| +1 | K111487 | NH-301 Ambulatory Ecg Analysis Software | Norav Medical Corp. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MLO? 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 MLO device
- #1 K261580 ZBPro Diagnostic (Version 2.0)score 13.8 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111487 | NH-301 Ambulatory Ecg Analysis Software | 2011 | 0 |
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, K111487 (Norav Medical Corp., 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MLO devicesMLO Electrocardiograph, Ambulatory, With Analysis Algorithm: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MLO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLO
238in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MLO
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MLO
4in 2025
MAUDE reports naming product code MLO, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 5 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 3 | 238 | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 2 | 2 |
| 2025 | 1 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Norav Holter Analysis System is intended for patients requiring ambulatory {Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: A . 1) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3) Evaluation of patients for ST segment changes. 4) Evaluation of a patient’s response…
Read the full statement (128 words)
The Norav Holter Analysis System is intended for patients requiring ambulatory {Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below: A .
1) Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.
2 ) Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.
3) Evaluation of patients for ST segment changes.
4) Evaluation of a patient’s response after resuming occupational or recreational activities (e.g. after M.. or cardiac surgery.)
5) Clinical and epidemiological Research Studies
6) Norav Holter Systems containing Heart Rate Variability (HRV) software have been tested to measure Heart Rate Variability within 4 ms tolerance. The clinical significance of Heart Rate Variability measures should be determined by a physician.
7) Evaluation of patients with pacemakers.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012712 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012712: Norav Holter System, Model NH-300 V1.07.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012712
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026