510(k) Report

510(k) · Cleared

Cleared

Non Invasive Vascular Program

K932852510(k) TraditionalCleared Feb 4, 1994239-day reviewClass I21 CFR 862.1815

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

D. E. Hokanson, Inc. · JOB Hexane Extraction, Fluorescence, Vitamin E

Cleared on Feb 4, 1994 after a 239-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Feb 4, 1994
Review
239 days
Class
Class I
Product code
JOB
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K932852Source: 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), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JOB? 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’s file for it is a 510(k) statement, which names no predicate.

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 JOB devices

JOB Hexane Extraction, Fluorescence, Vitamin E: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOB

FDA has decided no JOB device since 2007.

Median 510(k) review, days · JOB

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

Recalls per year · JOB

No recall names JOB since 2007.

Adverse event reports per year · JOB

No MAUDE report names JOB 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 D. E. Hokanson, Inc.

19 FDA decisions under this applicant name. See the company

  • K041689Polyurethane Blood Pressure CuffsD. E. Hokanson, Inc. · 2004
  • K033156OB1 Obstetrical DopplerD. E. Hokanson, Inc. · 2003
  • K023707A16 Blood Flow Measurement SystemD. E. Hokanson, Inc. · 2003
  • K982707EC6 PlethysmographD. E. Hokanson, Inc. · 1998
  • K973426Ans 2000 Ecg Monitor and Respiration PacerD. E. Hokanson, Inc. · 1998

https://510kreport.com/device/K932852 · printed Nov 4, 2026

Cite this page

510(k) Report. “K932852: Non Invasive Vascular Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K932852

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026