510(k) Report

510(k) · Cleared

Cleared

Ultrasonic Diagnostic System, Mod. 202

K800364510(k) TraditionalCleared Mar 12, 198021-day reviewClass II21 CFR 862.3150

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

Hoffrel Instruments, Inc. · DKX Thin Layer Chromatography, Barbiturate

Cleared on Mar 12, 1980 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 12, 1980
Review
21 days
Class
Class II
Product code
DKX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K800364Source: 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 DKX devices

DKX Thin Layer Chromatography, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DKX

FDA has decided no DKX device since 2007.

Median 510(k) review, days · DKX

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

Recalls per year · DKX

No recall names DKX since 2007.

Adverse event reports per year · DKX

No MAUDE report names DKX 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 Hoffrel Instruments, Inc.

12 FDA decisions under this applicant name. See the company

  • K870850MOD 482Hoffrel Instruments, Inc. · 1987
  • K860235Mod 426, Medical Ultrasonic Diagnostc TransducerHoffrel Instruments, Inc. · 1986
  • K850165Motor Drive, Mechanical Sector Scanning-MOD417Hoffrel Instruments, Inc. · 1985
  • K844916Model 518 & 519 Ultrasonoscope W/DopplerHoffrel Instruments, Inc. · 1985
  • K834277MOD 427Hoffrel Instruments, Inc. · 1984

Recent decisions in DKX

The DKX category page

  • K030211Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016Icn Biomedicals, Inc. · 2003

https://510kreport.com/device/K800364 · printed Nov 6, 2026

Cite this page

510(k) Report. “K800364: Ultrasonic Diagnostic System, Mod. 202.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K800364

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