510(k) · Cleared
ClearedPC ECG 1200
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 22, 2000 after a 289-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 7 later devices descend from it.
- Decided
- Nov 22, 2000
- Review
- 289 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK000404 PC ECG 1200Norav Medical, Ltd. · 2000
- Descendant · cites it directly · 3 of its ownK080141 PC Ecg 1200W SystemNorav Medical, Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK042981 Hyperq SystemBiological Signal Processing, Ltd. · 2005
- Descendant · 2 generations on · 1 of its ownK100813 QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS…Pulse Biomedical, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK070624 Hyperq SystemBiological Signal Processing, Ltd. · 2007
- Descendant · 3 generations on · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K080141PC Ecg 1200W SystemNorav Medical, Ltd. · 2008 · cites it directly3descendants
- K042981Hyperq SystemBiological Signal Processing, Ltd. · 2005 · cites it directly2descendants
- K100813QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card UsbPulse Biomedical, Inc. · 2010 · 2 generations on1descendant
- K070624Hyperq SystemBiological Signal Processing, Ltd. · 2007 · 2 generations on1descendant
- K142352CardiacLinxRoss Medical Technology, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000404 | PC ECG 1200 | Norav Medical, Ltd. | 2000 | — |
| +1 | K080141 | PC Ecg 1200W System | Norav Medical, Ltd. | 2008 | — |
| +1 | K042981 | Hyperq System | Biological Signal Processing, Ltd. | 2005 | — |
| +2 | K100813 | QRS Card S-T Segment Analysis Patient Monitoring System Model: QRS Card Usb | Pulse Biomedical, Inc. | 2010 | — |
| +2 | K070624 | Hyperq System | Biological Signal Processing, Ltd. | 2007 | — |
| +3 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
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 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K080141 (Norav Medical, Ltd., 2008) has gone furthest, with 3 descendants of its own.
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.
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 | — |
https://510kreport.com/device/K000404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000404: PC ECG 1200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000404
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026