510(k) · Cleared
ClearedAlexander Manufacturing CO. Rechargeable Battery Part Number MS06224
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 Jul 3, 1997 as substantially equivalent to K945964 (Sherwood Medical Co., 1995) after a 29-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 3, 1997
- Review
- 29 days
- Class
- Class II
- Product code
- MRZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K945964 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK945964 Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSherwood Medical Co. · 1995
- This deviceK972089 Alexander Manufacturing CO. Rechargeable Battery Part Number MS06224Alexander Mfg. Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration Sets | Sherwood Medical Co. | 1995 | — |
| 0 (this device) | K972089 | Alexander Manufacturing CO. Rechargeable Battery Part Number MS06224 | 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 |
|---|---|---|---|
| * | K945964 | Kangaroo (R) 524 Enteral Feeding Pump and Administration SetsSummary page 3…: K AF20§ — Device Name: MS06224 - Indications for Use: Replacement battery for Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor'… | 1995 |
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.
- 2 other devices also cite its predicate K945964.
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 Sherwood Medical Systems 10489 Kangaroo Feeding Pump Models 524, 224, 324, 510(k) Number K945964.
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/K972089 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972089: Alexander Manufacturing CO. Rechargeable Battery Part Number MS06224.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972089
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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