510(k) · Cleared
Recalled · 2009Restraint Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. T. Posey Co. · FMQ Restraint, Protective
Cleared on Nov 22, 1996 after an 84-day review. The FDA summary names its predicate without a number. It has been recalled 22 times.
- Decided
- Nov 22, 1996
- Review
- 84 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- 22
- 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? (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 |
|---|---|---|---|
| * | — | Protective Restraints 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2009 | Not classified | Z-2268-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2272-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2257-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2254-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2256-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2274-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2260-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2267-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2261-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2264-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2263-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2269-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2265-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2275-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2255-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2259-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2273-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2266-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2271-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2270-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2258-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
| Apr 20, 2009 | Not classified | Z-2262-2009 | Employee error | Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination… |
The 5 latest of 22 recalls; the web page lists all.
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 devices included in this 510(k) submission facilitate attachment of protective restraint devices to vehicles. These devices provide anchor points for tying quick release knots and/or adapts protective restraints with quick release buckles. The products are then secured to the bed, geriatric chair, or wheelchair via the accessory device. The accessory devices attach directly to the vehicle.
These products are facilitate attachment of devices that are intended to hinder egress or aid in positioning of a patient in a wheelchair, hospital bed, geriatric chair, or gumey.
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/K963436 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963436: Restraint Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963436
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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