510(k) · Cleared
ClearedSeer MC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems Information Technologies · MLO Electrocardiograph, Ambulatory, With Analysis Algorithm
Cleared on Sep 2, 2005 as substantially equivalent to K882818 (Marquette Electronics, Inc., 1989) and 1 other predicate after a 331-day review. Its family tree reaches back 2 generations to 1991. 1 later device descends from it.
- Decided
- Sep 2, 2005
- Review
- 331 days
- Class
- Class II
- Product code
- MLO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K911097 (1991). 3 ancestors in all, the oldest K882818 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK911097 PR4Mortara Instrument, Inc. · 1991
- 1 generation backK021373 H12+Holter RecorderMortara Instrument, Inc. · 2002
- This deviceK042782 Seer MCGe Medical Systems Information Technologies · 2005
- Descendant · cites it directly · 0 of its ownK142468 Stealth Monitor, Stealth Docking Cable, Stealth DSD Software…Cardiac Insight, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K142468Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth…Cardiac Insight, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911097 | PR4 | Mortara Instrument, Inc. | 1991 | — |
| −1 | K021373 | H12+Holter Recorder | Mortara Instrument, Inc. | 2002 | — |
| 0 (this device) | K042782 | Seer MC | Ge Medical Systems Information Technologies | 2005 | — |
| +1 | K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation… | Cardiac Insight, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K882818 | SEERSummary page 1…Holter Recorder Classification Names: 21 CFR 870.2800 Electrocardiograph,ambulatory, with analysis algorithm Predicate Devices: SEER® (K882818) Mortara H12+ Holter Recorder (K021373) Device Description: SEER MC is a H… | 1989 |
| * | K021373 | H12+Holter RecorderSummary page 1…ocardiograph,ambulatory, with analysis algorithm Predicate Devices: SEER® (K882818) Mortara H12+ Holter Recorder (K021373) Device Description: SEER MC is a Holter Recorder designed to be used in conjunction with an… | 2002 |
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 |
|---|---|---|---|
| K142468 | Stealth Monitor, Stealth Docking Cable, Stealth DSD Software Installation Disk, Stealth… | 2015 | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K142468 (Cardiac Insight, Inc., 2015) 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 SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up…
Read the full statement (304 words)
The SEER MC Ambulatory Digital Analysis Recorder is intended to provide ambulatory ECG signal and automated analysis of the recorded ECG data. Results of the automated analysis, when used in conjunction with an ECG review system, are intended to assist the physician in the interpretation of the recorded data. This information is not intended to serve as a substitute for the physician overread of the recorded ECG data. The SEER MC can collect and store up to 48 hours of continuous 2 or 3 channels of ambulatory ECG data. In addition, the SEER MC can record and analyze 12-lead ambulatory ECG data for definition of morphology shape and measurements, heart rate, rhythm, and ST segment trending. The SEER MC is intended for use on adult and pediatric (greater than 10Kg) patients in a clinical setting by qualified medical personnel.
The SEER MC in its 2 or 3 channel mode of operation detects the following: normal beats, ventricular beats, supraventricular beats, paced beats and artifact. This information, in conjunction with an ECG review system, documents tile following: fastest and slowest heart rate, runs of ventricular beats, runs of supraventricular beats, pauses, ST segment changes, areas of atrial fibrillation, percentage of paced beats, prolonged QT, T-Wave Alternans, Heart Rate Turbulence, Heart Rate Variability and ECG strips associated with patient events and/or symptoms.
The SEER MC in its 12-lead mode of operation, in conjunction with a ECG Review system, documents the aforementioned information and also measures and trends the following 12 lead parameters: PR interval, QT ii'u:,ral, QRS duration, ST measurements at J point plus 40, 60 and 80 mseconds for all 12 leads and displays the Ventricular rate, and P, R and T axis for each 12-lead segment.
The SEER MC is not intended to be used as a substitute for a standard, diagnostic-quality 12-lead electrocardiograph.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042782: Seer MC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042782
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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