510(k) Report

510(k) · Cleared

Cleared

Schul-Tec Immobilizer

K926291510(k) TraditionalCleared Mar 30, 1993106-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

Medical Emergency Support Equipment · IQK Orthosis, Cervical

Cleared on Mar 30, 1993 after a 106-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Mar 30, 1993
Review
106 days
Class
Class I
Product code
IQK
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K926291Source: 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 lists a 510(k) statement for it but has not posted the file, 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—

Recent decisions in IQK

The IQK category page

  • K930730Dormie Neck Support SystemThe Western Diagnostics Co. · 1993
  • K896042Medical Disposable BeddingKeystone Veterinary Supplies, Inc. · 1990
  • K895477Nova PillowNova Health Systems, Inc. · 1990
  • K882264Battle Creek PillowBattle Creek Equipment Co. · 1988
  • K850465Cervical Collars & Head HaltersAbco Dealers, Inc. · 1985

https://510kreport.com/device/K926291 · printed Nov 4, 2026

Cite this page

510(k) Report. “K926291: Schul-Tec Immobilizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926291

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