510(k) Report

510(k) · Cleared

Cleared

Adjustable Arm Support

K770065510(k) TraditionalCleared Feb 2, 197721-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

Richard F. Kronner, M.D. · IOY Support, Arm

Cleared on Feb 2, 1977 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 2, 1977
Review
21 days
Class
Class I
Product code
IOY
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K770065Source: 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 IOY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 IOY devices

IOY Support, Arm: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IOY

FDA has decided no IOY device since 2007.

Median 510(k) review, days · IOY

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

Recalls per year · IOY

No recall names IOY since 2007.

Adverse event reports per year · IOY

7in 2024

2007: 22008: 42009: 22010: 52011: 12012: 92013: 142014: 142015: 32016: 122017: 22018: 32019: 62020: 162021: 252022: 132023: 242024: 7
2007high 25 (2021) · low 0 (2025)2025

MAUDE reports naming product code IOY, 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—02
20080—04
20090—02
20100—05
20110—01
20120—09
20130—014
20140—014
20150—03
20160—012
20170—02
20180—03
20190—06
20200—016
20210—025
20220—013
20230—024
20240—07
20250—00
20260—0—

More from Richard F. Kronner, M.D.

3 FDA decisions under this applicant name. See the company

  • K800502Additional Components Kronner CompresRichard F. Kronner, M.D. · 1980
  • K770066Tibial Compression Fram for FracturesRichard F. Kronner, M.D. · 1977

https://510kreport.com/device/K770065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K770065: Adjustable Arm Support.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K770065

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