510(k) · Cleared
ClearedModel 950-12L Holter Recorder Without Analysis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Memtec Corp. · MWJ Electrocardiograph, Ambulatory (Without Analysis)
Cleared on Dec 9, 2010 as substantially equivalent to K022540 (Rozinn Electronics, Inc., 2002) and 3 other predicates after a 79-day review. Its family tree reaches back 4 generations to 1987. 3 later devices descend from it.
- Decided
- Dec 9, 2010
- Review
- 79 days
- Class
- Class II
- Product code
- MWJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K871344 (1987). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871344 Pathfinder 3, Auto Surveyor and SurveyorReynolds Medical, Ltd. · 1987
- 3 generations backK951902 Pathfinder 700 Holter AnalyzerReynolds Medical, Ltd. · 1996 · Recalled
- 2 generations backK990727 Syneflash & SyneviewEla Medical, Inc. · 1999
- 1 generation backK032466 SpiderviewEla Medical, Inc. · 2003
- This deviceK102723 Model 950-12L Holter Recorder Without AnalysisMemtec Corp. · 2010
- Descendant · cites it directly · 1 of its ownK103706 The Core (Cardiac Outpatient Realtime Ecg) MonitorApplied Cardiac Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK181658 MobileECG 2 BTMemtec Corporation · 2019
- Descendant · 2 generations on · 0 of its ownK142352 CardiacLinxRoss Medical Technology, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871344 | Pathfinder 3, Auto Surveyor and Surveyor | Reynolds Medical, Ltd. | 1987 | — |
| −3 | K951902 | Pathfinder 700 Holter Analyzer | Reynolds Medical, Ltd. | 1996 | 1 |
| −2 | K990727 | Syneflash & Syneview | Ela Medical, Inc. | 1999 | — |
| −1 | K032466 | Spiderview | Ela Medical, Inc. | 2003 | — |
| 0 (this device) | K102723 | Model 950-12L Holter Recorder Without Analysis | Memtec Corp. | 2010 | — |
| +1 | K103706 | The Core (Cardiac Outpatient Realtime Ecg) Monitor | Applied Cardiac Systems, Inc. | 2011 | — |
| +1 | K181658 | MobileECG 2 BT | Memtec Corporation | 2019 | — |
| +2 | K142352 | CardiacLinx | Ross Medical Technology, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
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 MWJ? 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 MWJ device
- #1 K254119 Wearable ECG Recorder (YMHeart XY-12)…score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K022540 | Cardio ID+(RZ153+)Summary page 1…1 Predicated Devices The legally marketed predicated devices to which equivalence is being claimed is: Rozinn Electronics RZ1 53+ K022540 Northeast Monitoring DR180 11 K001288 Ela Medical SpiderView… | 2002 |
| * | K001288 | DR180-IISummary page 1…equivalence is being claimed is: Rozinn Electronics RZ1 53+ K022540 Northeast Monitoring DR180 11 K001288 Ela Medical SpiderView K032466 Braemar Inc. DigirrakPlus… | 2000 |
| * | K032466 | SpiderviewSummary page 1…Z1 53+ K022540 Northeast Monitoring DR180 11 K001288 Ela Medical SpiderView K032466 Braemar Inc. DigirrakPlus K993617 Description of Device The Model 950-12L is a small, l… | 2003 |
| * | K993617 | Digitrakplus Holter RecorderSummary page 1…R180 11 K001288 Ela Medical SpiderView K032466 Braemar Inc. DigirrakPlus K993617 Description of Device The Model 950-12L is a small, light weight, single battery device designed for the recording of ECG da… | 1999 |
What descends from it? (3)
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?
- The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K103706 (Applied Cardiac Systems, Inc., 2011) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K022540.
How does its category compare?
All MWJ devicesMWJ Electrocardiograph, Ambulatory (Without Analysis): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MWJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MWJ
337in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWJ
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWJ
8in 2025
MAUDE reports naming product code MWJ, 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 | 5 | 142 | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 5 |
| 2010 | 3 | 90 | 0 | 0 |
| 2011 | 3 | 206 | 0 | 0 |
| 2012 | 1 | — | 0 | 2 |
| 2013 | 3 | 241 | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 4 | 337 | 0 | 6 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 2 | — | 2 | 3 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 5 | 270 | 0 | — |
What is it indicated for?
The Model 950-12L Halter recorder is intended to record continuous data for up to 120 hours for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as: *Palpitations, shortness of breath, chest pain, syncope *Evaluating pacemakers *Heart rate variability's *Evaluating medications *Clinical studies This is a prescriptive device and is to be used by trained physicians and other licensed medical…
Read the full statement (106 words)
The Model 950-12L Halter recorder is intended to record continuous data for up to 120 hours for the detection of arrhythmias in ambulatory patients. Such monitoring is frequently used for patient symptoms such as:
*Palpitations, shortness of breath, chest pain, syncope
*Evaluating pacemakers
*Heart rate variability's
*Evaluating medications
*Clinical studies
This is a prescriptive device and is to be used by trained physicians and other licensed medical professionals only.
The Memtec Model 950-12L recorder does not perform diagnostics. The data provided shall be used by physicians for diagnostic evaluations.
The Memtec Model 950-12L recorder is not intended for infants weighing less than 22 Lbs. (10 Kg).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102723: Model 950-12L Holter Recorder Without Analysis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102723
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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