510(k) · Cleared
ClearedCenturion Protective Restraint, SCR Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri-State Hospital Supply Corp. · FMQ Restraint, Protective
Cleared on Aug 28, 2008 as substantially equivalent to K963439 (J. T. Posey Co., 1996) after a 191-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 28, 2008
- Review
- 191 days
- Class
- Class I
- Product code
- FMQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K963439 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK963439 Pediatric Limb HoldersJ. T. Posey Co. · 1996
- This deviceK080448 Centurion Protective Restraint, SCR SeriesTri-State Hospital Supply Corp. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963439 | Pediatric Limb Holders | J. T. Posey Co. | 1996 | — |
| 0 (this device) | K080448 | Centurion Protective Restraint, SCR Series | Tri-State Hospital Supply Corp. | 2008 | — |
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 |
|---|---|---|---|
| * | K963439 | Pediatric Limb HoldersSummary page 1…General Hospital Predicate SE Device(s): This product is similar in design, composition, function, and method of use to the Posey Company Pediatric Limb Holder (K963439). Description: The Centurion® Protective Restraint is a device comprised of hook and loop material, 100% nylon fabric with polyes… | 1996 |
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 FMQ devicesFMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 Centurion® Protective Restraint is a device, including a wristlet, anklet, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.
This device is intended for use on neonatal/newborn patients by or on the order of a physician in a hospital or clinic setting.
The device is contraindicated for use on patients with dislocations, fractures, open wounds on the affected limb, or if I.V. site can be compromised.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080448 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080448: Centurion Protective Restraint, SCR Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080448
Report an extraction error
Are you the manufacturer?
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