510(k) · Cleared
ClearedPatient Protective Limb
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kenad SG Medical, Inc. · FMQ Restraint, Protective
Cleared on Oct 2, 1996 after an 89-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Oct 2, 1996
- Review
- 89 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 FMQ? 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K823815 | Patient Protective Limb Holder Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2…o Patient Protective Limb Holder from Danek Medical, Inc. Danek successfully filed a premarket notification for Patient Protective Limb Holder at Document Control number K823815, January 17, 1983. DEVICE DESCRIPTION (807.92(a)(4)) (p 11) General Description The Kenad Limb Holders subject to this Premark… |
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 FMQ devicesFMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMQ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · FMQ
Too few FMQ 510(k)s in any year since 2007 to give a median.
Recalls per year · FMQ
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FMQ
14in 2025
MAUDE reports naming product code FMQ, 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 | 16 |
| 2008 | 1 | — | 2 | 10 |
| 2009 | 1 | — | 22 | 42 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 1 | — | 0 | 31 |
| 2012 | 0 | — | 1 | 71 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 0 | — | 2 | 43 |
| 2015 | 0 | — | 0 | 33 |
| 2016 | 0 | — | 0 | 24 |
| 2017 | 0 | — | 0 | 54 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 1 | 57 |
| 2020 | 0 | — | 0 | 38 |
| 2021 | 0 | — | 1 | 33 |
| 2022 | 0 | — | 0 | 54 |
| 2023 | 0 | — | 0 | 47 |
| 2024 | 0 | — | 0 | 58 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Kenad Limb Holders are indicated for medical purposes where a patient's arm and leg movement must be limited to the extent necessary for treatment, examination or protection of the patient or others.
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/K962626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962626: Patient Protective Limb.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962626
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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