510(k) · Cleared
ClearedPolyester Pil Wrist/Ankle Restraint/Wrist Restraint Universal/Soft Flannel Wrist/Ankle Restraint/Foam Limb Holder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · FMQ Restraint, Protective
Cleared on Nov 6, 1996 after a 68-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 6, 1996
- Review
- 68 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (4)
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 |
|---|---|---|---|
| * | — | Foam Limb Holder w/Quick Release Buckle Named without a submission number | |
| * | — | Polyester Pile Wrist/Ankle Restraint Named without a submission number | |
| * | — | Soft Flannel Wrist/Ankle Restraint Named without a submission number | |
| * | — | Wrist Restraint, Universal 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 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?
The Zimmer line of restraints is intended for restless, confused, elderly, or unsteady patients. They help prevent such patients from injuring themselves or clinical personnel. The most common emergency indications for patient restraints are: emotional/psychological disturbance, threatened or attempted suicide, suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints may also be indicated for post-op patients in recovery, patients under…
Read the full statement (101 words)
The Zimmer line of restraints is intended for restless, confused, elderly, or
unsteady patients. They help prevent such patients from injuring themselves or
clinical personnel.
The most common emergency indications for patient restraints are:
emotional/psychological disturbance, threatened or attempted suicide,
suspected drug/alcohol abuse, and seizure or cardiac arrest. Restraints
may also be indicated for post-op patients in recovery, patients under
sedation, and patients suffering from stroke, neuromuscular disorders, or
Alzheimer's disease.
Zimmer restraints are not intended for patients who may be exceptionally
violent. Such patients may require devices made from heavier materials
and specifically designed for patients with serious mental disturbances.”
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/K963431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963431: Polyester Pil Wrist/Ankle Restraint/Wrist Restraint Universal/Soft Flannel Wrist/Ankle Restraint/Foam Limb Holder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963431
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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