510(k) Report

510(k) · Cleared

Cleared

37-701-1 Patient Doase Monitor with Detectors

K860469510(k) TraditionalCleared Apr 16, 198669-day reviewClass II21 CFR 892.5900

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

Victoreen, Inc. · KPZ Generator, High Voltage, X-Ray, Therapeutic

Cleared on Apr 16, 1986 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Apr 16, 1986
Review
69 days
Class
Class II
Product code
KPZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K860469Source: 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 KPZ? 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 KPZ devices

KPZ Generator, High Voltage, X-Ray, Therapeutic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPZ

FDA has decided no KPZ device since 2007.

Median 510(k) review, days · KPZ

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

Recalls per year · KPZ

No recall names KPZ since 2007.

Adverse event reports per year · KPZ

1in 2017

2017: 1
2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code KPZ, 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—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Victoreen, Inc.

40 FDA decisions under this applicant name. See the company

  • K982937Model 580-006 Radiation Therapy Ionization ChamberVictoreen, Inc. · 1998
  • K974112Vacudap, Model 2000, 2001Victoreen, Inc. · 1998
  • K973960MODEL 37-185Victoreen, Inc. · 1998
  • K964952Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997
  • K964785Veridose DiodesVictoreen, Inc. · 1997

Recent decisions in KPZ

The KPZ category page

  • K912249Patient Dose MonitorTheta Systems, Inc. · 1991
  • K854410VeriflexOld Delft Corp. of America · 1986

https://510kreport.com/device/K860469 · printed Nov 6, 2026

Cite this page

510(k) Report. “K860469: 37-701-1 Patient Doase Monitor with Detectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K860469

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