510(k) Report

510(k) · Cleared

Cleared

Amco Replacement Battery for Philips Medical Models BT1 and M5070A

K091548510(k) TraditionalCleared Aug 7, 200972-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

Amco International Manufacturing & Design, Inc. · MKJ Automated External Defibrillators (Non-Wearable)

Cleared on Aug 7, 2009 as substantially equivalent to K955628 (Heartstream, Inc., 1996) and 3 other predicates after a 72-day review. Its family tree reaches back 2 generations to 2000.

Decided
Aug 7, 2009
Review
72 days
Class
Class III
Product code
MKJ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K003565 (2000). 5 ancestors in all, the oldest K955628 (1996). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1996: 1 other ancestorK003565 · Heartstream FR2 Aed, Model M3860A,M3861A · Agilent Technologies, Inc. · 2000 · recalledK040904 · Philips Heartstart Home Defibrillator, Model M5068A · Philips Medical Systems · 2004 · recalled1995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors K040904 · Philips Heartstart Home Defibrillator, Model M5068A · Philips Medical Systems · 2004 · recalledK003565 · Heartstream FR2 Aed, Model M3860A,M3861A · Agilent Technologies, Inc. · 2000 · recalled0
  1. Root · 2 generations backK003565 Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc. · 2000 · Recalled
  2. 1 generation backK040904 Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems · 2004 · Recalled
  3. This deviceK091548 Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc. · 2009
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003565Heartstream FR2 Aed, Model M3860A,M3861AAgilent Technologies, Inc.200012
−1K040904Philips Heartstart Home Defibrillator, Model M5068APhilips Medical Systems20047
0 (this device)K091548Amco Replacement Battery for Philips Medical Models BT1 and M5070AAmco International Manufacturing & Design, Inc.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
200210
200510
FIG. 1 — Lineage of K091548, 2000–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K955628Fore Runner External Defibrillator/Defibrillator Pads
Summary page 1
…e Devices: Philips Medical Replacement Battery ForeRunner BT1 Defibrillator - Approved under K955628 Philips Medical Replacement Battery HeartStart FRx On-Site / Home…
Heartstream, Inc.1996—
*K020715Philips M5066A and M5068A
Summary page 1
…Philips Medical Replacement Battery HeartStart FRx On-Site / Home AED - Approved under K020715, K040904, K050004 Classification: Cardiovascular Panel Class 21 CFR 870.5300 DC-Defibrillator…
Philips Medical Systems200212
*K040904Philips Heartstart Home Defibrillator, Model M5068A
Summary page 1
…Philips Medical Replacement Battery HeartStart FRx On-Site / Home AED - Approved under K020715, K040904, K050004 Classification: Cardiovascular Panel Class 21 CFR 870.5300 DC-Defibrillator…
Philips Medical Systems20047
*K050004Philips Heartstart FRX Defibrillator, Model 861304
Summary page 1
…Philips Medical Replacement Battery HeartStart FRx On-Site / Home AED - Approved under K020715, K040904, K050004 Classification: Cardiovascular Panel Class 21 CFR 870.5300 DC-Defibrillator…
Philips Medical Systems20057

Also cleared against K955628: 6 other devices →

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 9 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 4 of the 5 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K955628.

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. 2009, this device’s year, is highlighted.

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—

What is it indicated for?

The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture.

The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical I HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. This battery has a shelf life of 4 years from the date of manufacture.

Indications for use as stated in the FDA summary.

Also cleared against K955628

6 other devices cite the same predicate.

  • K120350Extended Life BatteryAed Battery Exchange, LLC · 2012
  • K041883Skintact Multifunction Electrodes, Model DF 21Leonhard Lang GmbH · 2004
  • K013896Sentry Semiautomatic External Defibrillator; External Defibrillation Pads (Electrodes) DDP-100; Battery Pack…Defibtech, LLC · 20025 recalls
  • K991910Lifepak 12 BiphasicPhysio-Control Corp. · 19993 recalls
  • K983393Lifepak 500 BiphasicPhysio-Control Corp. · 19991 recall
  • K982264Firstsave Biphasic Models 9200 and 9210Survivalink Corp. · 1999

More from Amco International Manufacturing &…

5 FDA decisions under this applicant name. See the company

  • K082861Amco Replacement Battery for Powerheart Aed, Non-Rechargeable, Model 2L561; G3, Non-Rechargable, Model 7L561Amco International Manufacturing & Design, Inc. · 2008
  • K073716Life+Cel or Lifecel BatteryAmco International Manufacturing & Design, Inc. · 2008
  • K072596Life+Cel or Lifecel Battery Pack, Model 5L500Amco International Manufacturing & Design, Inc. · 2008
  • K071164Life+Cel BatteryAmco International Manufacturing & Design, Inc. · 2007

Recent decisions in MKJ

The MKJ category page

  • P160015/S029AED 3 Defibrillator with Uni-PadzZOLL Medical Corporation · 2026
  • P160022/S056ZOLL R Series Monitor/DefibrillatorZOLL Medical Corporation · 2026
  • P160022/S054X Series®, R Series®, AED Pro®, AED 3™ BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode…ZOLL Medical Corporation · 2026
  • P160026/S074Lifepak 1000 Defibrillator, Lifepak 20 Defibrillator/ Monitor, Lifepak 20E Defibrillator/ Monitor, Lifepak…Physio-Control, Inc. · 2026
  • P160026/S073LIFEPAK® 15 monitor/defibrillatorPhysio-Control, Inc. · 2026

https://510kreport.com/device/K091548 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091548: Amco Replacement Battery for Philips Medical Models BT1 and M5070A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091548

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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