510(k) Report

510(k) · Cleared

Cleared

Protective Restraint

K110377510(k) TraditionalCleared Apr 25, 201175-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

Medi-Tech Intl. Corp. · FMQ Restraint, Protective

Cleared on Apr 25, 2011 as substantially equivalent to K963413 (J. T. Posey Co., 1996) after a 75-day review. Its family tree reaches back 1 generation to 1996.

Decided
Apr 25, 2011
Review
75 days
Class
Class I
Product code
FMQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963413 (1996). No later device cites it as a predicate yet.

K963413 · Multiple Limb Holders · J. T. Posey Co. · 1996 · recalled1995200020052010
K963413 · Multiple Limb Holders · J. T. Posey Co. · 1996 · recalled0
  1. Root · 1 generation backK963413 Multiple Limb HoldersJ. T. Posey Co. · 1996 · Recalled
  2. This deviceK110377 Protective RestraintMedi-Tech Intl. Corp. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963413Multiple Limb HoldersJ. T. Posey Co.19962
0 (this device)K110377Protective RestraintMedi-Tech Intl. Corp.2011—
FIG. 1 — Lineage of K110377, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K963413Multiple Limb Holders
Summary page 1
…: Protective Restraint CLASSIFICATION NAME: Restraint, Protective (FMQ) PREDICATE OR LEGALLY MARKETED DEVICE: J.T.POSEY COMPANY Protective Restraint (K9634 13) DEVICE DESCRIPTION: The Medi-Tech International Corp. Protective Restraint is a protective restraint device which is intended…
J. T. Posey Co.19962

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 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. 2011, this device’s year, is highlighted.

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?

Medi-Tech International Corporations Easy-View Mitts are intended to be utilized as a patient safety device when patients are assessed at risk of disrupting life-saving treatments or could cause self-injury.

Indications for use as stated in the FDA summary.

More from Medi-Tech Intl. Corp.

3 FDA decisions under this applicant name. See the company

  • K002666Diamond Aloe Vera, SterileMedi-Tech Intl. Corp. · 2001
  • K864124Spand-Gel Granulated GelMedi-Tech Intl. Corp. · 1986

Recent decisions in FMQ

The FMQ category page

  • 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
  • K010644Cinch-Type Disposable Limb Holders, Model 912025Skil-Care Corp. · 2001

https://510kreport.com/device/K110377 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110377: Protective Restraint.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110377

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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