510(k) · Cleared
Recalled · 2004Accessaed, Semi-Automatic External Defibrillators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Access Cardiosystems, Inc. · MKJ Automated External Defibrillators (Non-Wearable)
Cleared on Aug 14, 2002 as substantially equivalent to K003565 (Agilent Technologies, Inc., 2000) and 2 other predicates after a 149-day review. Its family tree reaches back 3 generations to 1995. It has been recalled 2 times.
- Decided
- Aug 14, 2002
- Review
- 149 days
- Class
- Class III
- Product code
- MKJ
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943301 (1995). 9 ancestors in all, the oldest K832833 (1984). No later device cites it as a predicate yet.
- Root · 3 generations backK943301 Quik ComboPhysio-Control Corp. · 1995
- 2 generations backK955854 Lifepak 500Physio-Control Corp. · 1996 · Recalled
- 1 generation backK983393 Lifepak 500 BiphasicPhysio-Control Corp. · 1999 · Recalled
- This deviceK020984 Accessaed, Semi-Automatic External DefibrillatorsAccess Cardiosystems, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943301 | Quik Combo | Physio-Control Corp. | 1995 | — |
| −2 | K955854 | Lifepak 500 | Physio-Control Corp. | 1996 | 2 |
| −1 | K983393 | Lifepak 500 Biphasic | Physio-Control Corp. | 1999 | 1 |
| 0 (this device) | K020984 | Accessaed, Semi-Automatic External Defibrillators | Access Cardiosystems, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K003565 | Heartstream FR2 Aed, Model M3860A,M3861ASummary page 1…cation: Automatic External Defibrillator Class I11 21 CFR 870.1025 Predicate Devices: Heartstream FR2 AED (K003565) Physio-Control Biphasic LifePak 500 (K983393) Zoll M Series Biphasic Defibrillator (K990762) Indications for Use:… | 2000 |
| * | K983393 | Lifepak 500 BiphasicSummary page 1…Class I11 21 CFR 870.1025 Predicate Devices: Heartstream FR2 AED (K003565) Physio-Control Biphasic LifePak 500 (K983393) Zoll M Series Biphasic Defibrillator (K990762) Indications for Use: The AccessAEDTMsemi-automatic external defibrillator… | 1999 |
| * | K990762 | Zoll M Series with Rectilinear BI-Phasic Option (M Series BI-Phasic)Summary page 1…CFR 870.1025 Predicate Devices: Heartstream FR2 AED (K003565) Physio-Control Biphasic LifePak 500 (K983393) Zoll M Series Biphasic Defibrillator (K990762) Indications for Use: The AccessAEDTMsemi-automatic external defibrillator is intended to be used for the treatment of cardiac a… | 1999 |
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
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 3, 2004 | Not classified | Z-0199-05 | Other | Device may fail to deliver shock due to a faulty circuit board |
| Dec 19, 2003 | Not classified | Z-0356-04 | Other | Difibrillator may fail to operate due to a faulty component on the circuit board |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 3 other devices also cite its predicate K003565.
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 AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse. The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level…
Read the full statement (127 words)
The AccessAED™ semi-automatic external defibrillator is intended to be used for the treatment of cardiac arrest. The AccessAED should be applied to victims who are unconscious, with absence of breathing, and absence of a detectable pulse.
The AccessALS™ has the capability for manual operation by a user trained in advanced cardiac life support (ALS). In manual mode, the user can select the time for rhythm analysis, device charging, energy level, synchronization, and shock delivery. In the semi-automatic mode, AccessALS functions identically to the AccessAED.
The AccessAED and AccessALS are not currently indicated for children less than 8 years old (less than approximately 25 kgs. or 55 lbs.) The use of the AccessAED and AccessALS should be reviewed after each event and all adverse events should be reported.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020984 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020984: Accessaed, Semi-Automatic External Defibrillators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020984
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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