510(k) · Cleared
ClearedAlexander Manufacturing CO. Rechargeable Battery Part Number M12/500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexander Mfg. Co. · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Jul 3, 1997 as substantially equivalent to K884307 (Y, 1988) after a 48-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Jul 3, 1997
- Review
- 48 days
- Class
- Class II
- Product code
- LDR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K884307 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK884307 Ivac (R) Volumetric Controller - Model 262Y · 1988
- This deviceK971826 Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500Alexander Mfg. Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884307 | Ivac (R) Volumetric Controller - Model 262 | Y | 1988 | — |
| 0 (this device) | K971826 | Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500 | Alexander Mfg. Co. | 1997 | — |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LDR? 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 LDR device
- #1 K232316 DEKA Infusion System, DEKA Administration Setscore 10.5 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
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 | Decided |
|---|---|---|---|
| * | K884307 | Ivac (R) Volumetric Controller - Model 262Summary page 3…= s10(k) Number: 1<4 3 §256 -~ Device Name: M12/500 = - = Indications for Use: Replacement battery for IVAC Corp. 123233 230, 530, 600 Infusion Controller, 510(k) Number K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor’… | 1988 |
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?
- Its one ancestor has no recall.
How does its category compare?
All LDR devicesLDR Controller, Infusion, Intravascular, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDR
Too few LDR 510(k)s in any year since 2007 to give a median.
Recalls per year · LDR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDR
3in 2023
MAUDE reports naming product code LDR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Replacement battery for IVAC Corp. 123233 230, 530, 600 Infusion Controller, 510(k) Number K884307. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor’s replacement battery. The biomedical equipment technician therefore knows the intended use is as a replacement battery.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971826: Alexander Manufacturing CO. Rechargeable Battery Part Number M12/500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971826
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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