510(k) · Cleared
ClearedPedi-Spider Strap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergency Products and Research · NZD Stretcher, Patient Restraint
Cleared on Aug 17, 2006 after a 59-day review. The FDA summary names its predicate without a number.
- Decided
- Aug 17, 2006
- Review
- 59 days
- Class
- Class I
- Product code
- NZD
- 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 NZD? 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 |
|---|---|---|---|
| * | — | Pedo Cush Pedo Cuddle 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 NZD devicesNZD Stretcher, Patient Restraint: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NZD
FDA has decided no NZD device since 2007.
Median 510(k) review, days · NZD
Too few NZD 510(k)s in any year since 2007 to give a median.
Recalls per year · NZD
No recall names NZD since 2007.
Adverse event reports per year · NZD
3in 2023
MAUDE reports naming product code NZD, 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 | 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 | 3 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height. The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board. This would…
Read the full statement (189 words)
The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board, by the use of a checker board series of straps that are placed over the patient and secure to the back board with Velcro hook and loop closures on each side of the back board. The device should be used on children from 10 to 100 pounds and 12 to 55 inches in height.
The Pedi-Spider strap is designed for securing a pediatric patient to a long spine board. This would be used in the event of an injury, or suspected injury to the spinal area of a pediatric patient. The purpose of this device is to immobilize the patient while being stabilized at the scene of an emergency and during the transport of the patient to a treating medical facility. The device works by having a series of straps that are placed over the body of the patient and secured to the sides of the backboard with loop and hook closures. This series of straps are connected on each side and in the middle of the device to provide stability and extra rigidity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061721: Pedi-Spider Strap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061721
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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