510(k) · Cleared
ClearedVacudap, Model 2000, 2001
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victoreen, Inc. · KPR System, X-Ray, Stationary
Cleared on Jan 29, 1998 as substantially equivalent to K941931 (Victoreen, Inc., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jan 29, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K941931 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK941931 Diagnostic X-Ray Patient Exposure IndicatorVictoreen, Inc. · 1994
- This deviceK974112 Vacudap, Model 2000, 2001Victoreen, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941931 | Diagnostic X-Ray Patient Exposure Indicator | Victoreen, Inc. | 1994 | — |
| 0 (this device) | K974112 | Vacudap, Model 2000, 2001 | Victoreen, Inc. | 1998 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941931 | Diagnostic X-Ray Patient Exposure IndicatorSummary page 1…40-248-9300 Fax: 440-248-9301 Device Name: VacuDAP, Model 2000, 2001 Stationary X-ray System (accessory) redi vice: DAP(Dose-Area-Product) Meter, Model 07-205, 510(k) #K941931 The basic unit VacuDAP 2000 consists of the square ionization chamber and the chamber electronics including the high voltage gen… | 1994 |
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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
The Nuclear Associates VacuDAP - Model 2000, 2001 is intended to measure the radiation output of diagnostic X-ray generating machines during imaging of patients in both radiography and fluoroscopy. The instrument measures and displays Dose Area Product, a parameter that can be related to patient dose by a Medical Physicist. The Dose Area Product measurement includes the influence of dose rate, screening time and used field quantity variables. The instrument accumulates Dose Area Product values until manually reset by the user.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974112 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974112: Vacudap, Model 2000, 2001.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974112
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026