510(k) Report

510(k) · Cleared

Cleared

Add Line Devices (Parts) Electric Handpiece Systems

K935443510(k) TraditionalCleared Sep 20, 1994312-day reviewClass II21 CFR 872.4120

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

Osada Electric Co., Ltd. · DZH Saw, Bone, Ac-Powered

Cleared on Sep 20, 1994 after a 312-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Sep 20, 1994
Review
312 days
Class
Class II
Product code
DZH
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K935443Source: 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 DZH? 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 lists a 510(k) statement for it but has not posted the file, 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 DZH devices

DZH Saw, Bone, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DZH

FDA has decided no DZH device since 2007.

Median 510(k) review, days · DZH

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

Recalls per year · DZH

No recall names DZH since 2007.

Adverse event reports per year · DZH

2in 2017

2007: 62008: 52009: 42010: 32013: 12017: 2
2007high 6 (2007) · low 0 (2011)2025

MAUDE reports naming product code DZH, 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—06
20080—05
20090—04
20100—03
20110—00
20120—00
20130—01
20140—00
20150—00
20160—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Osada Electric Co., Ltd.

3 FDA decisions under this applicant name. See the company

  • K904742Osada EndexOsada Electric Co., Ltd. · 1990
  • K844250Osada EnacOsada Electric Co., Ltd. · 1985

Recent decisions in DZH

The DZH category page

  • K031793Dentatus OsciomatDentatus USA, Ltd. · 2003
  • K760958Surgical Oscillating SawAmerican Safety Equipment Corp. · 1976
  • K760957Surgical Reciprocating SawAmerican Safety Equipment Corp. · 1976

https://510kreport.com/device/K935443 · printed Nov 4, 2026

Cite this page

510(k) Report. “K935443: Add Line Devices (Parts) Electric Handpiece Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935443

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