510(k) · Cleared
ClearedNH-301 Ambulatory Ecg Analysis Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Norav Medical Corp. · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Nov 10, 2011 as substantially equivalent to K012712 (Norav Medical, Ltd., 2002) after a 163-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 10, 2011
- Review
- 163 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K012712 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK012712 Norav Holter System, Model NH-300 V1.07Norav Medical, Ltd. · 2002
- This deviceK111487 NH-301 Ambulatory Ecg Analysis SoftwareNorav Medical Corp. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K012712 | Norav Holter System, Model NH-300 V1.07 | Norav Medical, Ltd. | 2002 | — |
| 0 (this device) | K111487 | NH-301 Ambulatory Ecg Analysis Software | Norav Medical Corp. | 2011 | — |
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 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? (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 |
|---|---|---|---|
| * | K012712 | Norav Holter System, Model NH-300 V1.07Summary page 1…electrocardiograph, telephone Substantial Equivalence 21 CFR 807 92(a)(3) Norav's NH-300 Holter Analysis System k012712 for complete structural and functional identity of both software applications as well as their intended use and indications for u… | 2002 |
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.
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. 2011, this device’s year, is highlighted.
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 NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Halter) monitoring from i to 168 hours. Such monitoring is most frequently used for the following indications: 1. Evaluation of symptoms suggesting arrfhythmia or myocardial ischemnia. 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 patient's…
Read the full statement (125 words)
The NH-301 Ambulatory ECG Analysis Software is intended for patients requiring ambulatory (Halter) monitoring from i to 168 hours. Such monitoring is most frequently used for the following indications:
1. Evaluation of symptoms suggesting arrfhythmia or myocardial ischemnia.
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 patient's response after resuming occupational or recreational activities, (e.g.,
after Mil. or cardiac surgery.)
5. Clinical and epidemiological research studies.
6. Norav Hotter 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 as stated in the FDA summary.
https://510kreport.com/device/K111487 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111487: NH-301 Ambulatory Ecg Analysis Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111487
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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