510(k) Report

510(k) · Cleared

Cleared

Vagabond Soft Restraint System

K982178510(k) TraditionalCleared Jan 26, 1999218-day reviewClass I21 CFR 880.6760

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Emergent Innovations, Ltd. · FMQ Restraint, Protective

Cleared on Jan 26, 1999 after a 218-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 26, 1999
Review
218 days
Class
Class I
Product code
FMQ
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K982178Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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 devices

FMQ Restraint, Protective: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMQ

1in 2011

2008: 12009: 12011: 1
2007high 1 (2008) · low 0 (2007)2026

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

2008: 22009: 222012: 12014: 22019: 12021: 1
2007high 22 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FMQ

14in 2025

2007: 162008: 102009: 422010: 202011: 312012: 712013: 312014: 432015: 332016: 242017: 542018: 232019: 572020: 382021: 332022: 542023: 472024: 582025: 14
2007high 71 (2012) · low 10 (2008)2025

MAUDE reports naming product code FMQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—016
20081—210
20091—2242
20100—020
20111—031
20120—171
20130—031
20140—243
20150—033
20160—024
20170—054
20180—023
20190—157
20200—038
20210—133
20220—054
20230—047
20240—058
20250—014
20260—0—

What is it indicated for?

Vagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride. Vagabond for EMS Transport: This application is…

Read the full statement (254 words)

Vagabond for Neonatal Transport: This soft restraint system is indicated for transport of neonates from one hospital to another when isolets are necessary for perservation of life. The Vagabond Neonate Transport System safely insures the well being in the event of sudden jarring or accident. The neonate is proteced withi this special device from lateral or vertical movement due to collision or rough ride.

Vagabond for EMS Transport: This application is used for adults and pediatric patients when they are picked up in the field by Emergency Medical Service personnel and an EMS board is used for transport. Instead of using single straps the Vagabond provides eight points of secure side release locks along iwth a combination of webbing and netting to safely secure the patient to the baord for transport. *

!agalmnd.[o.LBaJmsc_Amflicafimb_The papoose application is necessary for the pediatric patients who “quire emergency room procedures sucha as suturing or other Minor procedures where they need to remain tionary. The Vagabond board and restrain system comfortabily holds the child in place and can serve as an aid for transport whent he child might need to be transferred to another dept. of a hospital. This is accomplished by merely lifting the patient and the board onto a cot or rolling bed.

int: This restraint is used when patients are sedated or disoriented and there is concern over thier falling out of bed. The Vagabond restraint helps to insure the safety of the patient by providing a comfortable restraint that serves to keep them in bed.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K982178: Vagabond Soft Restraint System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982178

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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