510(k) · Cleared
ClearedAlexander Box, Battery, Rechargeable
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexander Mfg. Co. · BWA Unit, Electrosurgical And Coagulation, With Accessories
Cleared on Apr 17, 1997 after a 238-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Apr 17, 1997
- Review
- 238 days
- Class
- Class II
- Product code
- BWA
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 BWA? 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
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | — | ANTEK Medical Telemetry Named without a submission number | |
| * | — | BIO-TEK Safety Analyzer Model 501 Named without a submission number | |
| * | — | Corometrics Medical PH Meter Named without a submission number | |
| * | — | International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer Named without a submission number | |
| * | — | Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator Named without a submission number |
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.
How does its category compare?
All BWA devicesBWA Unit, Electrosurgical And Coagulation, With Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BWA
FDA has decided no BWA device since 2007.
Median 510(k) review, days · BWA
Too few BWA 510(k)s in any year since 2007 to give a median.
Recalls per year · BWA
No recall names BWA since 2007.
Adverse event reports per year · BWA
5in 2025
MAUDE reports naming product code BWA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 22 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Power the ANTEK Medical Telemetry.
Power the BIO-TEK Safety Analyzer Model 501.
Power the Corometrics Medical PH Meter.
Power the International Technidyne Corp. Hemochron 400 and Blood Coagulator Timer.
Power the Syborn Corp. ACT Blood Pressure Monitor and Portable Blood Coagulator.
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/K963305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963305: Alexander Box, Battery, Rechargeable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963305
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026