510(k) · Cleared
ClearedHewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A
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 Dec 1, 1999 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Dec 1, 1999
- Review
- 89 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.
- This deviceK992977 Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A…Hewlett-Packard Co. · 1999
- Descendant · cites it directly · 0 of its ownK081371 Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · Recalled (Class I)
Class I recalls in this family
- K081371 Skintact Pediatric Multifunction Electrodes with…cites it directly · 2008
Most influential descendants
Showing 1 of 1 · See all- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992977 | Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A | Hewlett-Packard Co. | 1999 | — |
| +1 | K081371 | Skintact Pediatric Multifunction Electrodes with DH03 Gel | Leonhard Lang GmbH | 2008 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 Gel Class I | 2008 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K081371Skintact Pediatric Multifunction Electrodes with DH03 GelLeonhard Lang GmbH · 2008 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K081371 (Leonhard Lang GmbH, 2008) has gone furthest, with 0 descendants of its own.
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 Hewlett Packard External Pediatric electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device for single pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.…
Read the full statement (122 words)
The Hewlett Packard External Pediatric electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device for single pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.
When a patient requires defibrillation, cardioversion or extemal pacing, these electrodes will be applied to the pediatric paticnt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)
The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the
<+he Hewlett Packard Codemaster Defibrillator.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992977 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992977: Hewlett Packard Multifunction Pediatric Defib Function, Model M3503A & M3504A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992977
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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