510(k) Report

510(k) · Cleared

Cleared

Veenstra Instruments VDC-506 Dose Calibrator

K142325510(k) SpecialCleared Sep 18, 201429-day reviewClass II21 CFR 892.1360

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

Comecer Netherlands B.V. · KPT Calibrator, Dose, Radionuclide

Cleared on Sep 18, 2014 as substantially equivalent to K030066 (Nuclear Associates, 2003) after a 29-day review. Its family tree reaches back 1 generation to 2003.

Decided
Sep 18, 2014
Review
29 days
Class
Class II
Product code
KPT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K030066 (2003). No later device cites it as a predicate yet.

K030066 · Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 · Nuclear Associates · 20032000200520102015
K030066 · Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165 · Nuclear Associates · 20030
  1. Root · 1 generation backK030066 Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165Nuclear Associates · 2003
  2. This deviceK142325 Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V. · 2014
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K030066Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165Nuclear Associates2003—
0 (this device)K142325Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V.2014—
FIG. 1 — Lineage of K142325, 2003–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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 KPT? 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
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K030066Cal/Rad Mark VI/VDC-505 Dose Calibrator, Model 34-165
Summary page 4
…Predicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model Veenstra Instruments K030066 Nuclear Associates VDC-506 Dose Cal/Rad Mark VI/VDC-…
Nuclear Associates2003—

Also cleared against K030066: 1 other device →

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.
  • 1 other device also cites its predicate K030066.

How does its category compare?

All KPT devices

KPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · KPT

1in 2019

2007: 12009: 12010: 12014: 22017: 12019: 1
2007high 2 (2014) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPT

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

Recalls per year · KPT

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KPT

No MAUDE report names KPT since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20101—10
20110—10
20120—00
20130—00
20142—00
20150—00
20160—00
20171—00
20180—00
20191—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

Indications for use as stated in the FDA summary.

Also cleared against K030066

1 other device cites the same predicate.

  • K080297Medrad Intego Pet Infusion SystemMedrad, Inc. · 20081 recall

Recent decisions in KPT

The KPT category page

  • K192199CRC PC Smart Chamber K1Capintec, Inc. · 2019
  • K162394CRC-77tHRCapintec, Inc. · 2017
  • K141413CRC PC with Smart ChamberCapintec, Inc. · 2014
  • K101452Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWCapintec, Inc. · 2010
  • K090296Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336Biodex Medical Systems, Inc. · 20092 recalls

https://510kreport.com/device/K142325 · printed Nov 6, 2026

Cite this page

510(k) Report. “K142325: Veenstra Instruments VDC-506 Dose Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142325

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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