510(k) · Cleared
ClearedFoot Weight Alarm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleveland Medical Devices, Inc. · IRN Device, Warning, Overload, External Limb, Powered
Cleared on Dec 4, 1996 as substantially equivalent to K915326 (Bar Med Pty, Ltd., 1992) after a 155-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Dec 4, 1996
- Review
- 155 days
- Class
- Class II
- Product code
- IRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915326 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915326 Portable Limb Load Monitor (Bmllm-100)Bar Med Pty, Ltd. · 1992
- This deviceK962591 Foot Weight AlarmCleveland Medical Devices, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915326 | Portable Limb Load Monitor (Bmllm-100) | Bar Med Pty, Ltd. | 1992 | — |
| 0 (this device) | K962591 | Foot Weight Alarm | Cleveland Medical Devices, Inc. | 1996 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IRN? 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 |
|---|---|---|---|
| * | K915326 | Portable Limb Load Monitor (Bmllm-100)Summary page 1…ot Weight Alarm is substantially equivalent in design to the BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 BarMed Pty. Ltd. Portable Limb Load Monitor BMLLM-100 K915 326 H) Description: The Foot Weight Alarm is a foot shaped insole device to fit inside the patient's shoe to warn the patient when t… | 1992 |
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 IRN devicesIRN Device, Warning, Overload, External Limb, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IRN
FDA has decided no IRN device since 2007.
Median 510(k) review, days · IRN
Too few IRN 510(k)s in any year since 2007 to give a median.
Recalls per year · IRN
No recall names IRN since 2007.
Adverse event reports per year · IRN
No MAUDE report names IRN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Foot Weight Alarm is intended for use in the weight bearing training of patients with various orthopedic and neurological disabilities, such as malunion fracture, amputation, and cerebral vascular accident. The Foot Weight Alarm helps train patients by limiting the amount of force placed on the leg or helping a patient to reach a set amount of force in order to facilitate the return to normal gait pattern.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K962591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962591: Foot Weight Alarm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962591
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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