510(k) Report

510(k) · Cleared

Cleared

Overhead Arm Slings

K823811510(k) TraditionalCleared Jan 14, 198328-day reviewClass I21 CFR 890.3475

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

Danek Medical, Inc. · ILE Sling, Arm, Overhead Supported

Cleared on Jan 14, 1983 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 14, 1983
Review
28 days
Class
Class I
Product code
ILE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823811Source: 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 ILE devices

ILE Sling, Arm, Overhead Supported: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILE

FDA has decided no ILE device since 2007.

Median 510(k) review, days · ILE

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

Recalls per year · ILE

No recall names ILE since 2007.

Adverse event reports per year · ILE

1in 2018

2007: 12016: 12018: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code ILE, 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—01
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Danek Medical, Inc.

56 FDA decisions under this applicant name. See the company

  • K994122Bone Graft Washer, Model 9090114 - 9090118Danek Medical, Inc. · 2000
  • K993810CD Horizon Spinal SystemDanek Medical, Inc. · 2000
  • K993855Atlantis Anterior Cervical Plate SystemDanek Medical, Inc. · 1999
  • K991528Modification to Tenor Spinal System-Rod/Bolt ConnectorDanek Medical, Inc. · 1999
  • K990603Modification of the Zplate-Atl Anterior Fixation SystemDanek Medical, Inc. · 1999

Recent decisions in ILE

The ILE category page

  • K830842OB Help ArmLic-Orthion · 1983
  • K823152OB Help ArmOrthion Corp. · 1982

https://510kreport.com/device/K823811 · printed Nov 5, 2026

Cite this page

510(k) Report. “K823811: Overhead Arm Slings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K823811

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