510(k) Report

510(k) · Cleared

Cleared

Color Doppler Option to AI 5200 Diag Ultraso Syst

K910212510(k) TraditionalCleared Jul 11, 1991177-day reviewClass I21 CFR 874.4420

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

Acoustic Imaging Technologies Corp. · JYO Knife, Ear

Cleared on Jul 11, 1991 after a 177-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jul 11, 1991
Review
177 days
Class
Class I
Product code
JYO
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K910212Source: 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 JYO devices

JYO Knife, Ear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JYO

FDA has decided no JYO device since 2007.

Median 510(k) review, days · JYO

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

Recalls per year · JYO

No recall names JYO since 2007.

Adverse event reports per year · JYO

1in 2022

2014: 22015: 12019: 22022: 1
2007high 2 (2014) · low 0 (2007)2025

MAUDE reports naming product code JYO, 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—00
20100—00
20110—00
20120—00
20130—00
20140—02
20150—01
20160—00
20170—00
20180—00
20190—02
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Acoustic Imaging Technologies Corp.

3 FDA decisions under this applicant name. See the company

  • K923273AI 5200 Diagnostic Ultrasound SystemAcoustic Imaging Technologies Corp. · 1994
  • K924458AI5200 Diag Ultra Sound Syst Includ 7.5 & 10.0 MHZAcoustic Imaging Technologies Corp. · 1993

Recent decisions in JYO

The JYO category page

  • K841006Ear Knife-VariousPremier Dental Products Co. · 1984
  • K840764Ear KnivesSharpoint, Inc. · 1984
  • K833602Roller Knife-Transverse -SagittalMicrotek Medical, Inc. · 1984
  • K823911Knife Blade TipTreace Medical, Inc. · 1983
  • K772372Roller KnifeEdward Weck, Inc. · 1978

https://510kreport.com/device/K910212 · printed Nov 6, 2026

Cite this page

510(k) Report. “K910212: Color Doppler Option to AI 5200 Diag Ultraso Syst.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910212

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