510(k) · Cleared
ClearedAlexander Manufacturing CO. Rechargeable Battery # GL825-P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexander Mfg. Co. · MRZ Accessories, Pump, Infusion
Cleared on May 27, 1997 as substantially equivalent to K813403 (Travenol Laboratories, S.A., 1981) after a 55-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- May 27, 1997
- Review
- 55 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K813403 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK813403 Flo-Gard 8000 Infusion Pump SystemTravenol Laboratories, S.A. · 1981
- This deviceK971213 Alexander Manufacturing CO. Rechargeable Battery # GL825-PAlexander Mfg. Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813403 | Flo-Gard 8000 Infusion Pump System | Travenol Laboratories, S.A. | 1981 | — |
| 0 (this device) | K971213 | Alexander Manufacturing CO. Rechargeable Battery # GL825-P | 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 MRZ? 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 MRZ device
- #1 K193654 BlueStar Rxscore 7.5 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K813403 | Flo-Gard 8000 Infusion Pump SystemSummary page 3…. 270213 o Device Name: - GL825-P Indications for Use: Replacement battery for Baxter 64276002002 Flo-Guard 8000, 8100, 8200 Infusion Pumps {controller), 510(k) Number K813403. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor'… | 1981 |
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 MRZ devicesMRZ Accessories, Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MRZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MRZ
96in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MRZ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MRZ
35in 2025
MAUDE reports naming product code MRZ, 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 | 2 | — | 0 | 0 |
| 2008 | 4 | 96 | 0 | 0 |
| 2009 | 2 | — | 1 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 117 |
| 2016 | 2 | — | 0 | 55 |
| 2017 | 2 | — | 0 | 18 |
| 2018 | 1 | — | 1 | 46 |
| 2019 | 1 | — | 5 | 36 |
| 2020 | 2 | — | 0 | 44 |
| 2021 | 1 | — | 0 | 61 |
| 2022 | 1 | — | 0 | 39 |
| 2023 | 1 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 35 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Replacement battery for Baxter 64276002002 Flo-Guard 8000, 8100, 8200 Infusion Pumps (controller), 510(k) Number K813403.
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/K971213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971213: Alexander Manufacturing CO. Rechargeable Battery # GL825-P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971213
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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