510(k) Report

510(k) · Cleared

Cleared

Executive Collar

K811298510(k) TraditionalCleared May 27, 198116-day reviewClass I21 CFR 890.3490

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

Orthomedics · IQK Orthosis, Cervical

Cleared on May 27, 1981 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 27, 1981
Review
16 days
Class
Class I
Product code
IQK
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K811298Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IQK? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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 IQK devices

IQK Orthosis, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IQK

FDA has decided no IQK device since 2007.

Median 510(k) review, days · IQK

Too few IQK 510(k)s in any year since 2007 to give a median.

Recalls per year · IQK

1in 2024

2021: 12024: 1
2007high 1 (2021) · low 0 (2007)2026

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

Adverse event reports per year · IQK

6in 2025

2010: 12012: 22013: 32014: 72015: 72016: 202017: 112018: 172019: 12020: 22021: 32022: 22023: 32024: 32025: 6
2007high 20 (2016) · low 0 (2007)2025

MAUDE reports naming product code IQK, 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—00
20080—00
20090—00
20100—01
20110—00
20120—02
20130—03
20140—07
20150—07
20160—020
20170—011
20180—017
20190—01
20200—02
20210—13
20220—02
20230—03
20240—13
20250—06
20260—0—

More from Orthomedics

16 FDA decisions under this applicant name. See the company

  • K832740Femoral Fracture OrthosisOrthomedics · 1983
  • K832741Jason Cervical OrthosisOrthomedics · 1983
  • K832742Extension Control Knee OrthosisOrthomedics · 1983
  • K811456Ortho-Frac KitOrthomedics · 1981
  • K811297Cervical SupportOrthomedics · 1981

Recent decisions in IQK

The IQK category page

  • K930730Dormie Neck Support SystemThe Western Diagnostics Co. · 1993
  • K926291Schul-Tec ImmobilizerMedical Emergency Support Equipment · 1993
  • K896042Medical Disposable BeddingKeystone Veterinary Supplies, Inc. · 1990
  • K895477Nova PillowNova Health Systems, Inc. · 1990
  • K882264Battle Creek PillowBattle Creek Equipment Co. · 1988

https://510kreport.com/device/K811298 · printed Nov 4, 2026

Cite this page

510(k) Report. “K811298: Executive Collar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K811298

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026