510(k) Report

510(k) · Cleared

Cleared

The Sports Hand

K821619510(k) TraditionalCleared Jul 20, 198248-day reviewClass I21 CFR 890.3420

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

Therapeutic Recreation Systems, Inc. · IRA Hand, External Limb Component, Mechanical

Cleared on Jul 20, 1982 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 20, 1982
Review
48 days
Class
Class I
Product code
IRA
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K821619Source: 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 IRA devices

IRA Hand, External Limb Component, Mechanical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IRA

FDA has decided no IRA device since 2007.

Median 510(k) review, days · IRA

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

Recalls per year · IRA

No recall names IRA since 2007.

Adverse event reports per year · IRA

No MAUDE report names IRA 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 Therapeutic Recreation Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K791931Prehensile HandTherapeutic Recreation Systems, Inc. · 1979

Recent decisions in IRA

The IRA category page

  • K791931Prehensile HandTherapeutic Recreation Systems, Inc. · 1979

https://510kreport.com/device/K821619 · printed Nov 6, 2026

Cite this page

510(k) Report. “K821619: The Sports Hand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821619

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