510(k) Report

510(k) · Cleared

Cleared

Clavicle Support

K823157510(k) TraditionalCleared Nov 10, 198216-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

Warm & Form, Orthopedic Materials · IQJ Splint, Clavicle

Cleared on Nov 10, 1982 after a 16-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 10, 1982
Review
16 days
Class
Class I
Product code
IQJ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823157Source: 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.

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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 IQJ devices

IQJ Splint, Clavicle: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IQJ

FDA has decided no IQJ device since 2007.

Median 510(k) review, days · IQJ

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

Recalls per year · IQJ

No recall names IQJ since 2007.

Adverse event reports per year · IQJ

No MAUDE report names IQJ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Warm & Form, Orthopedic Materials

24 FDA decisions under this applicant name. See the company

  • K830245Head HalterWarm & Form, Orthopedic Materials · 1983
  • K830244Traction AccessoriesWarm & Form, Orthopedic Materials · 1983
  • K830243Abduction PillowWarm & Form, Orthopedic Materials · 1983
  • K830246Cast Shoe, Cast BootWarm & Form, Orthopedic Materials · 1983
  • K823659Pelvic Traction BeltWarm & Form, Orthopedic Materials · 1982

Recent decisions in IQJ

The IQJ category page

  • K823809Clavical StrapDanek Medical, Inc. · 1983
  • K823661Clavicle SupportWarm & Form, Orthopedic Materials · 1982
  • K760577Richards Clavicle StrapRichard'S Medical Equip., Inc. · 1976

https://510kreport.com/device/K823157 · printed Nov 6, 2026

Cite this page

510(k) Report. “K823157: Clavicle Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K823157

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