510(k) Report

510(k) · Cleared

Cleared

Ankle Weights

K823822510(k) TraditionalCleared Jan 14, 198328-day reviewClass I21 CFR 890.5350

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

Danek Medical, Inc. · IOD Components, Exercise

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
IOD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K823822Source: 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 IOD devices

IOD Components, Exercise: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOD

FDA has decided no IOD device since 2007.

Median 510(k) review, days · IOD

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

Recalls per year · IOD

No recall names IOD since 2007.

Adverse event reports per year · IOD

1in 2025

2012: 12016: 22017: 1442018: 152019: 12023: 12025: 1
2007high 144 (2017) · low 0 (2007)2025

MAUDE reports naming product code IOD, 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—00
20110—00
20120—01
20130—00
20140—00
20150—00
20160—02
20170—0144
20180—015
20190—01
20200—00
20210—00
20220—00
20230—01
20240—00
20250—01
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 IOD

The IOD category page

  • K831544Deluxe Traction Exercise Glove BK5035Fred Sammons, Inc. · 1983
  • K823648Surgical TubingFred Sammons, Inc. · 1983
  • K823600Solid Wood ConeFred Sammons, Inc. · 1982
  • K813632Color Coded Weight CuffsFred Sammons, Inc. · 1982
  • K812319Therapy BenchKaye Products, Inc. · 1981

https://510kreport.com/device/K823822 · printed Nov 5, 2026

Cite this page

510(k) Report. “K823822: Ankle Weights.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K823822

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