510(k) · Cleared

Cleared

Life+Cel Battery

K071164510(k) TraditionalCleared Dec 7, 2007225-day reviewClass II21 CFR 870.1025

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

Amco International Manufacturing & Design, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Dec 7, 2007 as substantially equivalent to K032051 (Access Battery, Inc., 2004) and 4 other predicates after a 225-day review. Its family tree reaches back 5 generations to 1985.

Decided: Dec 7, 2007
Review: 225 days
Class: Class II
Product code: MHX
Recalls: None
Predicates: 6

Its longest line of descent runs back 5 generations to K844187 (1985). 23 ancestors in all, the oldest K802718 (1980). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK844187 Siemens Sirecust 404N Neonatal MonitorSiemens Medical Solutions USA, Inc. · 1985
4 generations backK952054 Siemens Sirecust Monitoring (1200, 1200 Neo, 960)Siemens Medical Solutions USA, Inc. · 1996
3 generations backK962291 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
2 generations backK970920 Siemens SC9000/SC9015 Bedside Monitoring SystemSiemens Medical Solutions USA, Inc. · 1997
1 generation backK032051 Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P…Access Battery, Inc. · 2004
This deviceK071164 Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K844187	Siemens Sirecust 404N Neonatal Monitor	Siemens Medical Solutions USA, Inc.	1985	—
−4	K952054	Siemens Sirecust Monitoring (1200, 1200 Neo, 960)	Siemens Medical Solutions USA, Inc.	1996	—
−3	K962291	Siemens SC9000/SC9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	1997	—
−2	K970920	Siemens SC9000/SC9015 Bedside Monitoring System	Siemens Medical Solutions USA, Inc.	1997	—
−1	K032051	Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG…	Access Battery, Inc.	2004	—
0 (this device)	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	3	0
1995	6	0
1996	2	0
1998	1	0

FIG. 1 — Lineage of K071164, 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 MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MHX device

#1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K032051	Battery Pack, Rechargeable, Models MLA0051, MLA90479, MNC5169L/P, MNC1000EKG, MNC14649P Summary page 6 …dicate devices and submissions: 1. The AMCO 2L226 life+celTM is equivalent to that manufactured by: Alpha Source / Access Battery, cleared under K032051 * Unipower Corp., cleared under K940842 and K935111 * R & D Battery, cleared under K951281…	Access Battery, Inc.	2004	—
*	K940842	Unipower Rechargeable Battery Pack Summary page 6 …+celTM is equivalent to that manufactured by: Alpha Source / Access Battery, cleared under K032051 * Unipower Corp., cleared under K940842 and K935111 * R & D Battery, cleared under K951281 * OEM, GE Marquette - Patient Monitor Dash…	Unipower Corp.	1994	—
*	K935111	Unipowerr Rechargeable Battery Pack Summary page 6 …uivalent to that manufactured by: Alpha Source / Access Battery, cleared under K032051 * Unipower Corp., cleared under K940842 and K935111 * R & D Battery, cleared under K951281 * OEM, GE Marquette - Patient Monitor Dash 3000/4000…	Unipower Corp.	1994	—
*	K951281	R&D Batteris, Inc. Part Number 5024, 5027, 5033 and 5035 Summary page 6 …pha Source / Access Battery, cleared under K032051 * Unipower Corp., cleared under K940842 and K935111 * R & D Battery, cleared under K951281 * OEM, GE Marquette - Patient Monitor Dash 3000/4000 - Reference: K051367, K020290 (Battery…	R & D Batteries, Inc.	1995	—
Kept off the family tree	K920964	Alpha Source / Access Battery Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6 …(Battery included with device) 2. The AMCO 5L375 life+ceI TM is equivalent to that manufactured by: * Alpha Source / Access Battery, cleared under K920964 * Unipower Corp., cleared under K940842 and K935111 * R & D Battery, cleared under K951281…
*	K945869	R&D Part Nos. 5443, 5322, 5448, 5492 Summary page 7 …y: Alpha Source / Access Battery, cleared under K920964 · Unipower Corp., cleared under K940842 and K9351 11 * R & D Battery, cleared under K945869 * OEM, Health Dyne / Vickers Respironics - Smart Monitor 900 Series - Reference: K874695 (Battery included w…	R & D Batteries, Inc.	1995	—
*	—	OEM, GE Marquette - Patient Monitor Dash 3000/4000 Named without a submission number			—
*	—	OEM, Physio Control / Medtronic's - Monitor/Defibrillator (FastPak) LP5 Named without a submission number			—
*	—	OEM, Physio Control - Monitor/Defibrillator (Non-FastPak) LP5 / LP10 Named without a submission number			—
*	—	OEM, Physio Control / Medtronic's - Monitor/Defibrillator LP12 (NiCad) Named without a submission number			—
*	—	OEM, Health Dyne / Vickers Respironics - Smart Monitor 900 Series Named without a submission number			—
*	—	OEM, CAS Medical - NIBP Monitor 740 Named without a submission number			—
*	—	OEM, Physio Control / Medtronic's - Monitor/Defibrillator LP12 (SLA) Named without a submission number			—
†	K051367	Patient Monitor, Models Dash 3000, 4000 and 5000	Ge Medical Systems Information Technologies	2005	1
†	K020290	Dash 3000/4000 Patient Monitor	General Electric Medical Systems Information Techn	2002	1
†	K890079	Lifepak 10 Defibrillator/Monitor	Physio-Control Corp.	1989	1
†	K931053	Lifepak 10 Defibrillator/Monitor W/Opt Pacemaker	Physio-Control Corp.	1993	—
†	K973486	Life Pak 12	Physio-Control Corp.	1998	3
†	K010918	Lifepak 12 Defibrillator/Monitor System	Medtronic Physio-Control Corp.	2001	4
†	K874695	Healthdyne Apnea/Heart Monitor, Model 900	Healthdyne, Inc.	1988	—
†	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL…	Cas Medical Systems, Inc.	2004	1

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 22 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
1 of the 23 ancestors has a recall of any class.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

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

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)2025

MAUDE reports naming product code MHX, 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	15	96	3	131
2008	16	58	2	232
2009	13	57	7	382
2010	20	90	13	955
2011	12	81	16	949
2012	16	88	11	676
2013	21	120	14	1,997
2014	13	248	6	1,609
2015	14	203	5	1,284
2016	13	149	7	1,105
2017	14	134	6	1,115
2018	11	203	12	2,157
2019	7	243	6	1,462
2020	11	196	0	1,714
2021	5	195	0	2,423
2022	15	189	6	1,470
2023	8	229	3	2,254
2024	5	181	3	2,814
2025	8	192	15	3,761
2026	14	205	21	—

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 are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a…

Read the full statement (124 words)

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

configured.

Since rechargeable batteries and battery packs are "device specific", and are

designed to operate and fit into the equipment for which they were manufactured,

only qualified personnel should evaluate, test, charge, or install these devices.

This battery is shipped only to customers who request a replacement battery for

a particular device or to replace a competitor's replacement battery. Biomedical

equipment service professionals, EMT's, etc. therefore know that the intended

use is as a replacement battery.

Only replacement battery 2L226 in this submission (Patient Monitor) is provided

Over-the-Counter (OTC).

All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990,

and 9L998 in this submission (Defib/AED's) are provided by prescription only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071164 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071164: Life+Cel Battery.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071164

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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