510(k) · Cleared

Cleared

Patient Dose Monitor

K912249510(k) TraditionalCleared Aug 30, 1991101-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

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

Cleared on Aug 30, 1991 after a 101-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Aug 30, 1991
Review: 101 days
Class: Class II
Product code: KPZ
Recalls: None
Predicates: 0

2 later devices descend from it, 2 citing it directly.

This deviceK912249 Patient Dose MonitorTheta Systems, Inc. · 1991
Descendant · cites it directly · 0 of its ownK030175 2 BASICCapintec, Inc. · 2003
Descendant · cites it directly · 0 of its ownK964952 Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all

K0301752 BASICCapintec, Inc. · 2003 · cites it directly0descendants
K964952Veridose V (Five), Model Number 37-705Victoreen, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K912249	Patient Dose Monitor	Theta Systems, Inc.	1991	—
+1	K030175	2 BASIC	Capintec, Inc.	2003	—
+1	K964952	Veridose V (Five), Model Number 37-705	Victoreen, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
2003	1	0

FIG. 1 — Lineage of K912249, 1991–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030175	2 BASIC	Capintec, Inc.	2003	0
K964952	Veridose V (Five), Model Number 37-705	Victoreen, Inc.	1997	0

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.

What does this lineage say?

Of its descendants, K030175 (Capintec, Inc., 2003) has gone furthest, with 0 descendants of its own.

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

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

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K912249 · printed Nov 5, 2026

Cite this page

510(k) Report. “K912249: Patient Dose Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912249

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026