510(k) Report

510(k) · Cleared

Cleared

Ipos Anti-Adductus Shoe

K831690510(k) TraditionalCleared Jun 24, 198331-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

Ipos Luneburg · KNP Orthosis, Corrective Shoe

Cleared on Jun 24, 1983 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jun 24, 1983
Review
31 days
Class
Class I
Product code
KNP
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K831690Source: 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 KNP? 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 KNP devices

KNP Orthosis, Corrective Shoe: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNP

FDA has decided no KNP device since 2007.

Median 510(k) review, days · KNP

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

Recalls per year · KNP

No recall names KNP since 2007.

Adverse event reports per year · KNP

12in 2025

2009: 12010: 32011: 42012: 92013: 22014: 42015: 62016: 32017: 72018: 32019: 202020: 62021: 32022: 82023: 12024: 162025: 12
2007high 20 (2019) · low 0 (2007)2025

MAUDE reports naming product code KNP, 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—01
20100—03
20110—04
20120—09
20130—02
20140—04
20150—06
20160—03
20170—07
20180—03
20190—020
20200—06
20210—03
20220—08
20230—01
20240—016
20250—012
20260—0—

More from Ipos Luneburg

8 FDA decisions under this applicant name. See the company

  • K834143Nylon Compression Stump SheathIpos Luneburg · 1984
  • K833868Ipos G.L.P. SystemIpos Luneburg · 1983
  • K802977Ipocarbon Stretch StockinetteIpos Luneburg · 1980
  • K802976CarbonacrylIpos Luneburg · 1980
  • K800749Ipocon 7Ipos Luneburg · 1980

Recent decisions in KNP

The KNP category page

  • K831552Sorbothane Visco Inner Sole PadFred Sammons, Inc. · 1983
  • K823654Slip-on Sandals for Measuring ShortnessFred Sammons, Inc. · 1983
  • K823665Rotation BootWarm & Form, Orthopedic Materials · 1982
  • K810228SorbothaneHamilton Kent · 1981
  • K801743Plastazote ShoeAlimed, Inc. · 1980

https://510kreport.com/device/K831690 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831690: Ipos Anti-Adductus Shoe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831690

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