510(k) · Cleared
ClearedAlexander Manufacturing CO. Rechargeable Battery Part Number STR5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexander Mfg. Co. · BTA Pump, Portable, Aspiration (Manual Or Powered)
Cleared on Jun 5, 1997 as substantially equivalent to K951281 (R & D Batteries, Inc., 1995) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- Jun 5, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- BTA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K840110 (1984). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK840110 Laerdal Suction UnitLaerdal Medical Corp. · 1984
- This deviceK971107 Alexander Manufacturing CO. Rechargeable Battery Part Number STR5Alexander Mfg. Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K840110 | Laerdal Suction Unit | Laerdal Medical Corp. | 1984 | — |
| 0 (this device) | K971107 | Alexander Manufacturing CO. Rechargeable Battery Part Number STR5 | Alexander Mfg. Co. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
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 BTA? 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 BTA device
- #1 K222547 Electric nasal aspiratorscore 20.7 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K951281 | R&D Batteris, Inc. Part Number 5024, 5027, 5033 and 5035Summary page 3…H‘“””“““““”“““‘ i e 510(k) Number: K 47\\07 Device Name: STR5 Replacement Battery . - Indications for Use: Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018). .. 1his battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) " Numb… | 1995 |
| * | K942018 | R&D Batteries, Part NO. 5025, 5128 and 5183Summary page 3…““‘ i e 510(k) Number: K 47\\07 Device Name: STR5 Replacement Battery . - Indications for Use: Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018). .. 1his battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) " Number K840110.… | 1994 |
| * | K840110 | Laerdal Suction UnitSummary page 3…attery part number(s) 5025 (K#K951281 AND K942018). .. 1his battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) " Number K840110. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor'… | 1984 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K951281.
How does its category compare?
All BTA devicesBTA Pump, Portable, Aspiration (Manual Or Powered): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BTA
7so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · BTA
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BTA
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BTA
13in 2025
MAUDE reports naming product code BTA, 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 | 1 | — | 1 | 13 |
| 2008 | 3 | 135 | 3 | 5 |
| 2009 | 2 | — | 0 | 14 |
| 2010 | 2 | — | 3 | 178 |
| 2011 | 1 | — | 0 | 62 |
| 2012 | 1 | — | 0 | 47 |
| 2013 | 3 | 45 | 0 | 18 |
| 2014 | 3 | 91 | 0 | 399 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 149 | 0 | 25 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 4 | 125 | 0 | 17 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 1 | — | 0 | 10 |
| 2021 | 1 | — | 1 | 9 |
| 2022 | 3 | 58 | 0 | 7 |
| 2023 | 4 | 265 | 0 | 8 |
| 2024 | 5 | 131 | 0 | 13 |
| 2025 | 6 | 87 | 0 | 13 |
| 2026 | 7 | 89 | 0 | — |
What is it indicated for?
Replacement battery for R & D Battery part number(s) 5025 (K#K951281 AND K942018).
This battery is a replacement battery for Laerdal Medical Corp. 79-12-05 7050 Series Suction Cup, 510(k) Number K840110.
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/K971107 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971107: Alexander Manufacturing CO. Rechargeable Battery Part Number STR5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971107
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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