510(k) · Cleared
ClearedHewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hewlett-Packard Co. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Sep 4, 1998 as substantially equivalent to K951593 (Physio-Control Corp., 1995) and 4 other predicates after an 87-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Sep 4, 1998
- Review
- 87 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 2 generations to K895520 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK895520 Pagewriter Xli M1700A & Pagewriter XL M1701AHewlett-Packard Co. · 1990
- 1 generation backK954980 Pagewriter 200, 200I Cardiograph & Interpretive CardioHewlett-Packard Co. · 1996
- This deviceK982025 Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100…Hewlett-Packard Co. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K895520 | Pagewriter Xli M1700A & Pagewriter XL M1701A | Hewlett-Packard Co. | 1990 | — |
| −1 | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive Cardio | Hewlett-Packard Co. | 1996 | — |
| 0 (this device) | K982025 | Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100… | Hewlett-Packard Co. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 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 MKJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K951593 | Lifepak 11Summary page 1…arketed devices to which equivalencies are being claimed is the LifePak 11/11R, defibrillator / pacemaker / diagnostic cardiac monitor, manufactured by Physio- Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of… | 1995 |
| * | K912189 | Likepak 11 Cardiac Monit/Lifenet RS100 Rec StationSummary page 1…s to which equivalencies are being claimed is the LifePak 11/11R, defibrillator / pacemaker / diagnostic cardiac monitor, manufactured by Physio- Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of the #C90 opti… | 1992 |
| * | K935772 | HP M177XA CardiographsSummary page 1…pacemaker / diagnostic cardiac monitor, manufactured by Physio- Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of the #C90 option is substantially equivalent in safety and performance to the LifePak 11/11R and… | 1994 |
| * | K954980 | Pagewriter 200, 200I Cardiograph & Interpretive CardioSummary page 1…/ diagnostic cardiac monitor, manufactured by Physio- Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of the #C90 option is substantially equivalent in safety and performance to the LifePak 11/11R and M1770A… | 1996 |
| * | K981265 | Pagewriter 200I Interpretive Cardiograph Model M1770A with Acute Cardiac Ischemia Time… Cleared while this submission was under review Summary page 1…stic cardiac monitor, manufactured by Physio- Control, (K951593) and (K912189). Also, the M1770A Electrocardiograph, manufactured by Hewlett-Packard, (K935772, K954980, K981265). The design of the #C90 option is substantially equivalent in safety and performance to the LifePak 11/11R and M1770A features.… | 1998 |
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?
- The line of descent spans 8 years and passes through 1 company; a new generation was cleared every 5.8 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K951593.
How does its category compare?
All MKJ devicesMKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKJ
48in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKJ
156in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MKJ
1in 2025
Class I (23 since 2007) Class II/III not classified
Adverse event reports per year · MKJ
13,315in 2025
MAUDE reports naming product code MKJ, 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 | 7 | 69 | 12 | 3,958 |
| 2008 | 13 | 141 | 24 | 4,752 |
| 2009 | 8 | 165 | 37 | 6,782 |
| 2010 | 4 | 250 | 35 | 7,399 |
| 2011 | 11 | 36 | 7 | 8,170 |
| 2012 | 10 | 197 | 5 (1) | 9,732 |
| 2013 | 7 | 191 | 4 | 14,955 |
| 2014 | 11 | 196 | 24 (15) | 15,399 |
| 2015 | 6 | 156 | 1 | 16,129 |
| 2016 | 0 | — | 2 (1) | 17,062 |
| 2017 | 4 | — | 6 (4) | 16,684 |
| 2018 | 20 | — | 3 | 16,591 |
| 2019 | 25 | — | 6 (2) | 16,861 |
| 2020 | 52 | — | 2 | 16,197 |
| 2021 | 41 | — | 4 | 16,300 |
| 2022 | 19 | — | 3 | 14,867 |
| 2023 | 24 | — | 11 | 13,766 |
| 2024 | 27 | — | 5 | 15,109 |
| 2025 | 48 | — | 1 | 13,315 |
| 2026 | 31 | — | 3 | — |
What is it indicated for?
The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use. The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac arrhythmias. The 12-Lead feature can also be applied to patients for routine.…
Read the full statement (116 words)
The 12-Lead option (#C90) adds 12-Lead ECG functionality to the CodeMaster 100 monitor/defibrillator, M2475B. This feature will be used by emergency medical personnel who have been trained and authorized for its use.
The primary patient population for which this feature is intended is defined as persons with symptoms associated with acute myocardial infarction or cardiac arrhythmias. The 12-Lead feature can also be applied to patients for routine. medical examinations or anytime a baseline ECG is ordered by a physician. Note that a physician must review the preliminary report. Like any computer assisted ECG interpretation program, the predictive instrument evaluation is not a substitute for the physician’s decision process.
This product is not intended for home use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982025 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982025: Hewlett-Packard M2475B with 12-Lead Option (#C90) Codemaster 100 Conitor/Defibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982025
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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