510(k) · Cleared

Cleared

Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P

K032051510(k) TraditionalCleared Jan 9, 2004191-day reviewClass III21 CFR 870.5310

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

Access Battery, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Jan 9, 2004 as substantially equivalent to K982135 (Cas Medical Systems, Inc., 1998) and 12 other predicates after a 191-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.

Decided: Jan 9, 2004
Review: 191 days
Class: Class III
Product code: MKJ
Recalls: None
Predicates: 13

Its longest line of descent runs back 4 generations to K844187 (1985). 18 ancestors in all, the oldest K802718 (1980). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 4 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
3 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
2 generations backK962291 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
1 generation backK970920 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
This deviceK032051 Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P…Access Battery, Inc. · 2004
Descendant · cites it directly · 0 of its ownK071164 Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007

Most influential descendants

Showing 1 of 1 · See all

K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K844187	Siemens Sirecust 404N Neonatal Monitor	Siemens Medical Solutions USA, Inc.	1985	—
−3	K952054	Siemens Sirecust Monitoring (1200, 1200 Neo, 960)	Siemens Medical Solutions USA, Inc.	1996	—
−2	K962291	Siemens SC9000/SC9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	1997	—
−1	K970920	Siemens SC9000/SC9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	1997	—
0 (this device)	K032051	Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG…	Access Battery, Inc.	2004	—
+1	K071164	Life+Cel Battery	Amco International Manufacturing & Design, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1980	1	0
1983	1	0
1988	1	0
1989	1	0
1993	2	0
1994	1	0
1995	4	0
1996	2	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K032051, 1985–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (13)

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	Applicant	Decided	Recalls
*	K982135	Oscillomate Ems Nibp Monitor Model 9001 Summary page 2 …ubmissions: I The Access Battern'MLA0051 is the same as that used in CAS Medical Systems Series 9000 Blood Pressure Monitors, cleared under 510(k) Notifications K982135 and K925402. 2. The Access Battery MLA90479 is the same as that used in Spacclabs Medical Models 90478 and 90479 Telemctry…	Cas Medical Systems, Inc.	1998	—
*	K925402	Oscillomate Blood Pressure Monitor-Model 9300 Summary page 2 …I The Access Battern'MLA0051 is the same as that used in CAS Medical Systems Series 9000 Blood Pressure Monitors, cleared under 510(k) Notifications K982135 and K925402. 2. The Access Battery MLA90479 is the same as that used in Spacclabs Medical Models 90478 and 90479 Telemctry Receivers,…	Cas Medical Systems, Inc.	1993	—
*	K925510	Model 90478 & 90479 Telemetry Rec. Module&Housing Summary page 2 …25402. 2. The Access Battery MLA90479 is the same as that used in Spacclabs Medical Models 90478 and 90479 Telemctry Receivers, cleared under 5 10(k) Notification K9255 10. 3. The Access Battery MNC I 000EKG is the same as used in the Marquette Model 1200 Defibrillator, cleared under 510(k) No…	Spacelabs Medical, Inc.	1994	2
*	K882067	Marquette 1200 Defibrillator Summary page 2 …5 10(k) Notification K9255 10. 3. The Access Battery MNC I 000EKG is the same as used in the Marquette Model 1200 Defibrillator, cleared under 510(k) Notification K882067. 4. The Access Batterv MNC 1659L is the same as that used in the PPG Biomedical/Litton EK Series EKG Monitors. cleared und…	Marquette Electronics, Inc.	1988	—
*	K890875	Cardiotest EK53/EK53R, Cardiognost EK56/EK512 Summary page 2 …ication K882067. 4. The Access Batterv MNC 1659L is the same as that used in the PPG Biomedical/Litton EK Series EKG Monitors. cleared under 5 10(k) Notifications K890875 and K832015. 5. The Access Battery MNC4755 is the same as that used in Hcewlctt Packard's 4700 Series EKG Pagewvriter Elec…	Ppg Industries, Inc.	1989	—
*	K832015	Multiscriptor EK Various #43 Summary page 2 …067. 4. The Access Batterv MNC 1659L is the same as that used in the PPG Biomedical/Litton EK Series EKG Monitors. cleared under 5 10(k) Notifications K890875 and K832015. 5. The Access Battery MNC4755 is the same as that used in Hcewlctt Packard's 4700 Series EKG Pagewvriter Electrocardiogra…	Litton Medical Electronics	1983	—
*	K802718	Model 4700A Electrocardiograph Summary page 2 …5. 5. The Access Battery MNC4755 is the same as that used in Hcewlctt Packard's 4700 Series EKG Pagewvriter Electrocardiograph, cleared under 5 10(k) Notification K8027 18. 6. The Access Battery MNC 14649P is the same as that used in the Datascope/Medical Research Laboratories Passport Monitor…	Hewlett-Packard Co.	1980	—
*	K952085	DPD Defibrillator Summary page 2 …ry MNC 14649P is the same as that used in the Datascope/Medical Research Laboratories Passport Monitor & Defibrillator DPD. cleared under 5 10(k) Notifications K952085 and K930548. 7. The Access Battery MNC862988P is the same as that used in Burdick Eclipse 4 Model Electrocardiograph, clea…	Medical Research Laboratories, Inc.	1995	—
*	K930548	DPD Defibrillator Summary page 2 …P is the same as that used in the Datascope/Medical Research Laboratories Passport Monitor & Defibrillator DPD. cleared under 5 10(k) Notifications K952085 and K930548. 7. The Access Battery MNC862988P is the same as that used in Burdick Eclipse 4 Model Electrocardiograph, cleared under 51…	Medical Research Laboratories, Inc.	1993	—
*	K946281	Eclipse 4 Electrocardiograph	Burdick, Inc.	1996	—
*	K943959	Eclipse 4 Electrocardiograph Summary page 2 …K930548. 7. The Access Battery MNC862988P is the same as that used in Burdick Eclipse 4 Model Electrocardiograph, cleared under 510(k) Notifications K94628 I and K943959. 8. The Access Battern MNC431345P is the same as that used in Siemens Medical Bedside Monitoring System SC9000. cleared un…	Burdick, Inc.	1995	—
*	K970920	Siemens SC9000/SC9015 Bedside Monitoring System Summary page 2 …I and K943959. 8. The Access Battern MNC431345P is the same as that used in Siemens Medical Bedside Monitoring System SC9000. cleared under 5 10(k) Notifications K970920 and K96229 1. Description: Rechargeable batteries and battery packs arc utilized as a primar\ direct current (d-c) po\\er sourc…	Siemens Medical Solutions USA, Inc.	1997	—
*	K962291	Siemens SC9000/SC9015 Bedside Monitoring System Summary page 2 …59. 8. The Access Battern MNC431345P is the same as that used in Siemens Medical Bedside Monitoring System SC9000. cleared under 5 10(k) Notifications K970920 and K96229 1. Description: Rechargeable batteries and battery packs arc utilized as a primar\ direct current (d-c) po\\er source or as a sta…	Siemens Medical Solutions USA, Inc.	1997	—

Also cleared against K982135: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071164	Life+Cel Battery	Amco International Manufacturing & Design, Inc.	2007	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 19 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
1 of the 18 ancestors has a recall of any class.
Of its descendants, K071164 (Amco International Manufacturing & Design, Inc., 2007) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K982135.

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

2007high 52 (2020) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MKJ

156in 2015

2007high 250 (2010) · low 36 (2011)2026

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

Recalls per year · MKJ

1in 2025

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

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

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?

To power the functions of various devices for which batteries or battery packs are configured.

Since rechargeable batteries and battery packs arc "device specilic" and are designed to operate and fit into the equipment tor which Lhey were manufactured, only qualified personnel should evaluate, test, charge, or install these devices.

This battery is shipped only to customers who request a replacement baUery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals therefore know that the intended usc is as a replacement battery.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032051 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032051: Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032051

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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