510(k) Report

510(k) · Cleared

Cleared

Patient Restraints

K963906510(k) TraditionalCleared Dec 2, 199663-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

Safety Intl., Inc. · FMQ Restraint, Protective

Cleared on Dec 2, 1996 as substantially equivalent to K850470 (Abco Dealers, Inc., 1985) and 4 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1976.

Decided
Dec 2, 1996
Review
63 days
Class
Class I
Product code
FMQ
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K760618 (1976). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1985: 1 other ancestor1981: 1 other ancestor1978: 1 other ancestor1977: 1 other ancestorK760618 · Patient Restraint · Encompass Group, LLC · 197619751980198519901995
Other ancestors, by generation 1 generation back: 4 other ancestors K760618 · Patient Restraint · Encompass Group, LLC · 19760
  1. Root · 1 generation backK760618 Patient RestraintEncompass Group, LLC · 1976
  2. This deviceK963906 Patient RestraintsSafety Intl., Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K760618Patient RestraintEncompass Group, LLC1976—
0 (this device)K963906Patient RestraintsSafety Intl., Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
197810
198110
198510
FIG. 1 — Lineage of K963906, 1976–1996Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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
Get a 510(k) Report

What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K850470Bed Products
Summary page 1
…s Protective Restraints that FDA has found to be substantially equivalent to the pre- amendment devices. The following are some such devices: | Product Manufacturer K850470 Abco Restraint, Protective Biomet Restraint, Protective -~ | K780232 Dowling Textile Restraint, Protective K760618 Maddak Restr…
Abco Dealers, Inc.1985—
*K780232Restraint, Protective
Summary page 1
…ent to the pre- amendment devices. The following are some such devices: | Product Manufacturer K850470 Abco Restraint, Protective Biomet Restraint, Protective -~ | K780232 Dowling Textile Restraint, Protective K760618 Maddak Restraint, Protective K812473 Medical Restraints | Restraints, Protective K…
Biomet, Inc.1978—
*K760618Patient Restraint
Summary page 1
…ng are some such devices: | Product Manufacturer K850470 Abco Restraint, Protective Biomet Restraint, Protective -~ | K780232 Dowling Textile Restraint, Protective K760618 Maddak Restraint, Protective K812473 Medical Restraints | Restraints, Protective K771629 Device Description The Safety Interna…
Encompass Group, LLC1976—
*K812473Head Protector
Summary page 1
…Manufacturer K850470 Abco Restraint, Protective Biomet Restraint, Protective -~ | K780232 Dowling Textile Restraint, Protective K760618 Maddak Restraint, Protective K812473 Medical Restraints | Restraints, Protective K771629 Device Description The Safety International Corp.’s Patient Restraints are…
Maddak, Inc.1981—
*K771629Hand Restraint
Summary page 1
…Biomet Restraint, Protective -~ | K780232 Dowling Textile Restraint, Protective K760618 Maddak Restraint, Protective K812473 Medical Restraints | Restraints, Protective K771629 Device Description The Safety International Corp.’s Patient Restraints are easy to use devices which are used to secure patient…
Medical Restraints, Inc.1977—
*—Morrison Medical Products Restraint, Protective
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.

What does this lineage say?

  • None of the 5 ancestors has a 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?

The Safety International Corp. Restraint Belt is designed to effectively secure the patient on a ambulance cot, backboard, stretcher or wheelchairs. They are also used for application as wrist or ankle restraints in conjunction with the patient restraints already on the equipment on which the patient is being carried.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in FMQ

The FMQ category page

  • K110377Protective RestraintMedi-Tech Intl. Corp. · 2011
  • K081264Statstrap Neonatal Incubator Safety Strap, Models SS-001, SS-002Children'S Health First, Inc. · 2009
  • K080448Centurion Protective Restraint, SCR SeriesTri-State Hospital Supply Corp. · 2008
  • K013239Comfortcare Compression Support with Magnets Comfortcare Magnetic InsolesMed Gen, Inc. · 2001
  • K010818Infant Limb Holder, Models 306080 & 306081Skil-Care Corp. · 2001

https://510kreport.com/device/K963906 · printed Nov 6, 2026

Cite this page

510(k) Report. “K963906: Patient Restraints.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963906

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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