510(k) · Cleared

Cleared

R&D Part Nos. 5443, 5322, 5448, 5492

K945869510(k) TraditionalCleared Feb 27, 199588-day reviewClass I21 CFR 876.1500

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

R & D Batteries, Inc. · FCO Box, Battery, Rechargeable

Cleared on Feb 27, 1995 after an 88-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided: Feb 27, 1995
Review: 88 days
Class: Class I
Product code: FCO
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK945869 R&D Part Nos. 5443, 5322, 5448, 5492R & D Batteries, Inc. · 1995
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
0 (this device)	K945869	R&D Part Nos. 5443, 5322, 5448, 5492	R & D Batteries, Inc.	1995	—
+1	K071164	Life+Cel Battery	Amco International Manufacturing & Design, Inc.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K945869, 1995–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 FCO? 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? (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?

Of its descendants, K071164 (Amco International Manufacturing & Design, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FCO devices

FCO Box, Battery, Rechargeable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCO

FDA has decided no FCO device since 2007.

Median 510(k) review, days · FCO

Too few FCO 510(k)s in any year since 2007 to give a median.

Recalls per year · FCO

No recall names FCO since 2007.

Adverse event reports per year · FCO

5in 2023

2007high 22 (2007) · low 0 (2018)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	22
2008	—	2
2009	—	1
2010	—	1
2011	—	6
2012	—	1
2013	—	5
2014	—	2
2015	—	3
2016	—	18
2017	—	2
2018	—	0
2019	—	0
2020	—	1
2021	—	0
2022	—	0
2023	—	5
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K945869 · printed Nov 4, 2026

Cite this page

510(k) Report. “K945869: R&D Part Nos. 5443, 5322, 5448, 5492.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K945869

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026