510(k) Report

510(k) · Cleared

Recalled · 2011

CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose Calibrators

K071396510(k) SpecialCleared Jun 28, 200738-day reviewClass II21 CFR 892.1360Recalls 1

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

Capintec, Inc. · KPT Calibrator, Dose, Radionuclide

Cleared on Jun 28, 2007 after a 38-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled once.

Decided
Jun 28, 2007
Review
38 days
Class
Class II
Product code
KPT
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared20052010201520202025
  1. This deviceK071396 CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsCapintec, Inc. · 2007
  2. Descendant · cites it directly · 0 of its ownK090296 Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331…Biodex Medical Systems, Inc. · 2009 · Recalled

Most influential descendants

Showing 1 of 1 · See all
  • K090296Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336Biodex Medical Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K071396CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsCapintec, Inc.2007—
+1K090296Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335…Biodex Medical Systems, Inc.20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K071396, 2007–2009Source: FDA 510(k) summaries, read by 510(k) Report · 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 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
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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
*—CRC 15 Ultra
Named without a submission number
—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K090296Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336Biodex Medical Systems, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 8, 2011Not classifiedZ-0177-2012Software designSoftware error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K090296 (Biodex Medical Systems, Inc., 2009) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KPT devices

KPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy…

Read the full statement (108 words)

The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.

Indications for use as stated in the FDA summary.

More from Capintec, Inc.

14 FDA decisions under this applicant name. See the company

  • 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
  • K052595CRC 15ULTRACapintec, Inc. · 2005

Recent decisions in KPT

The KPT category page

  • K192199CRC PC Smart Chamber K1Capintec, Inc. · 2019
  • K162394CRC-77tHRCapintec, Inc. · 2017
  • K142325Veenstra Instruments VDC-506 Dose CalibratorComecer Netherlands B.V. · 2014
  • K141413CRC PC with Smart ChamberCapintec, Inc. · 2014
  • K101452Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWCapintec, Inc. · 2010

https://510kreport.com/device/K071396 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071396: CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071396

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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