510(k) Report

510(k) · Cleared

Recalled · 2007

Aedefibrillator

K002232510(k) TraditionalCleared Dec 6, 2000135-day reviewClass III21 CFR 870.5310Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Research Laboratories, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Dec 6, 2000 after a 135-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. It has been recalled 3 times.

Decided
Dec 6, 2000
Review
135 days
Class
Class III
Product code
MKJ
Recalls
3
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K002232Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 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
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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?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Aug 23, 2007Not classifiedZ-1223-2007Process controlFailure to deliver therapy: The Welch Allyn AED20 Defibrillators may display a "Defib Comm" error message on the device display during use which may result in failure of the device to analyze the patient's ECG and deliver the appropriate…
Jun 15, 2006Not classifiedZ-1106-06Nonconforming Material/ComponentThe Welch Allyn AED 20 Defibrillators may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropriate therapy.
Apr 28, 2005Not classifiedZ-0806-05Device DesignThe Welch Allyn AED 20 product may display a 'Defib Comm' error message on the device display during use which may result in a terminal failure of the device to analyze the patient's ECG and deliver the appropiate therapy.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MKJ devices

MKJ Automated External Defibrillators (Non-Wearable): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MKJ

48in 2025

2007: 72008: 132009: 82010: 42011: 112012: 102013: 72014: 112015: 62017: 42018: 202019: 252020: 522021: 412022: 192023: 242024: 272025: 482026 (partial year): 31
2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007: 69 days median2008: 141 days median2009: 165 days median2010: 250 days median2011: 36 days median2012: 197 days median2013: 191 days median2014: 196 days median2015: 156 days median
2007high 250 (2010) · low 36 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MKJ

1in 2025

2007: 122008: 242009: 372010: 352011: 72012: 5, 1 Class I2013: 42014: 24, 15 Class I2015: 12016: 2, 1 Class I2017: 6, 4 Class I2018: 32019: 6, 2 Class I2020: 22021: 42022: 32023: 112024: 52025: 12026 (partial year): 3
2007high 37 (2009) · low 1 (2015)2026

Class I (23 since 2007) Class II/III not classified

Adverse event reports per year · MKJ

13,315in 2025

2007: 3,9582008: 4,7522009: 6,7822010: 7,3992011: 8,1702012: 9,7322013: 14,9552014: 15,3992015: 16,1292016: 17,0622017: 16,6842018: 16,5912019: 16,8612020: 16,1972021: 16,3002022: 14,8672023: 13,7662024: 15,1092025: 13,315
2007high 17,062 (2016) · low 3,958 (2007)2025

MAUDE reports naming product code MKJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007769123,958
200813141244,752
20098165376,782
20104250357,399
2011113678,170
2012101975 (1)9,732
20137191414,955
20141119624 (15)15,399
20156156116,129
20160—2 (1)17,062
20174—6 (4)16,684
201820—316,591
201925—6 (2)16,861
202052—216,197
202141—416,300
202219—314,867
202324—1113,766
202427—515,109
202548—113,315
202631—3—

More from Medical Research Laboratories, Inc.

19 FDA decisions under this applicant name. See the company

  • K021168Jump Start, Model 970300Medical Research Laboratories, Inc. · 20027 recalls
  • K012766Portable Intensive Care UnitMedical Research Laboratories, Inc. · 2002
  • K012030Portable Intensive Care UnitMedical Research Laboratories, Inc. · 2001
  • K010207Portable Instensive Care UnitMedical Research Laboratories, Inc. · 2001
  • K000712Portable Intensive Care Unit, Model PicMedical Research Laboratories, Inc. · 2000

Recent decisions in MKJ

The MKJ category page

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https://510kreport.com/device/K002232 · printed Nov 5, 2026

Cite this page

510(k) Report. “K002232: Aedefibrillator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002232

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026