510(k) Report

510(k) · Cleared

Cleared

Prosana Belt

K812719510(k) TraditionalCleared Oct 6, 198111-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

Bandwagon, Inc. · IQE Orthosis, Lumbar

Cleared on Oct 6, 1981 after an 11-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 6, 1981
Review
11 days
Class
Class I
Product code
IQE
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K812719Source: 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 IQE devices

IQE Orthosis, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IQE

FDA has decided no IQE device since 2007.

Median 510(k) review, days · IQE

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

Recalls per year · IQE

No recall names IQE since 2007.

Adverse event reports per year · IQE

2in 2018

2009: 12013: 12014: 12018: 2
2007high 2 (2018) · low 0 (2007)2025

MAUDE reports naming product code IQE, 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—00
20110—00
20120—00
20130—01
20140—01
20150—00
20160—00
20170—00
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in IQE

The IQE category page

  • K821682Truncal OrthosisSurgical Appliance Industries, Inc. · 1982
  • K820051Obus Forme Orthopedic Brace, UprightObus Forme, Ltd. · 1982
  • K810450Truncal OrthosisFred Sammons, Inc. · 1981

https://510kreport.com/device/K812719 · printed Nov 5, 2026

Cite this page

510(k) Report. “K812719: Prosana Belt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K812719

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