510(k) · Cleared
ClearedMS401097-17,MS722-K,MS720,MS721,MS722
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alexander Mfg. Co. · HLJ Ophthalmoscope, Battery-Powered
Cleared on Jul 3, 1997 as substantially equivalent to K832437 (Keeler Instruments, Inc., 1983) after a 352-day review. Its family tree reaches back 1 generation to 1983.
- Decided
- Jul 3, 1997
- Review
- 352 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K832437 (1983). No later device cites it as a predicate yet.
- Root · 1 generation backK832437 Medic Lux Diagnostic SetsKeeler Instruments, Inc. · 1983
- This deviceK962767 MS401097-17,MS722-K,MS720,MS721,MS722Alexander Mfg. Co. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K832437 | Medic Lux Diagnostic Sets | Keeler Instruments, Inc. | 1983 | — |
| 0 (this device) | K962767 | MS401097-17,MS722-K,MS720,MS721,MS722 | 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 HLJ? 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? (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 |
|---|---|---|---|
| * | K832437 | Medic Lux Diagnostic SetsSummary page 3…62767 _ e s L Device Namae) Indications for Use: Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1918-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor'… | 1983 |
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 HLJ devicesHLJ Ophthalmoscope, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLJ
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HLJ
140in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLJ
No recall names HLJ since 2007.
Adverse event reports per year · HLJ
1in 2023
MAUDE reports naming product code HLJ, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | 140 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Replacement battery for Site Micro Surgical Systems (Keeler Optical) 1918-P-5020 Medic Lux 1919-P-5020, 510(k) Number K832437.
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/K962767 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962767: MS401097-17,MS722-K,MS720,MS721,MS722.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962767
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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