510(k) · Cleared

Cleared

R&D Batteries, Part NO. 5025, 5128 and 5183

K942018510(k) TraditionalCleared Jul 25, 199490-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 Jul 25, 1994 after a 90-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: Jul 25, 1994
Review: 90 days
Class: Class I
Product code: FCO
Recalls: None
Predicates: 0

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

This deviceK942018 R&D Batteries, Part NO. 5025, 5128 and 5183R & D Batteries, Inc. · 1994
Descendant · cites it directly · 0 of its ownK971107 Alexander Manufacturing CO. Rechargeable Battery Part Number STR5Alexander Mfg. Co. · 1997

Most influential descendants

Showing 1 of 1 · See all

K971107Alexander Manufacturing CO. Rechargeable Battery Part Number STR5Alexander Mfg. Co. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K942018	R&D Batteries, Part NO. 5025, 5128 and 5183	R & D Batteries, Inc.	1994	—
+1	K971107	Alexander Manufacturing CO. Rechargeable Battery Part Number STR5	Alexander Mfg. Co.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K942018, 1994–1997Source: 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
K971107	Alexander Manufacturing CO. Rechargeable Battery Part Number STR5	Alexander Mfg. Co.	1997	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, K971107 (Alexander Mfg. Co., 1997) 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/K942018 · printed Nov 6, 2026

Cite this page

510(k) Report. “K942018: R&D Batteries, Part NO. 5025, 5128 and 5183.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942018

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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