510(k) Report

510(k) · Cleared

Cleared

CRC PC Smart Chamber K1

K192199510(k) SpecialCleared Sep 12, 201930-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

Capintec, Inc. · KPT Calibrator, Dose, Radionuclide

Cleared on Sep 12, 2019 as substantially equivalent to K141413 (Capintec, Inc., 2014) after a 30-day review. Its family tree reaches back 1 generation to 2014.

Decided
Sep 12, 2019
Review
30 days
Class
Class II
Product code
KPT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K141413 (2014). No later device cites it as a predicate yet.

K141413 · CRC PC with Smart Chamber · Capintec, Inc. · 2014201020122014201620182020
K141413 · CRC PC with Smart Chamber · Capintec, Inc. · 20140
  1. Root · 1 generation backK141413 CRC PC with Smart ChamberCapintec, Inc. · 2014
  2. This deviceK192199 CRC PC Smart Chamber K1Capintec, Inc. · 2019
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K141413CRC PC with Smart ChamberCapintec, Inc.2014—
0 (this device)K192199CRC PC Smart Chamber K1Capintec, Inc.2019—
FIG. 1 — Lineage of K192199, 2014–2019Source: 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
*K141413CRC PC with Smart Chamber
Summary page 4
…of the predicate device, CRC-PC Smart Chamber series, which received FDA clearance under 510(k) number K141413 Manufacturer: Capintec, Inc. 7 Vreeland Road Florham Park, New Jersey 07932 USA…
Capintec, Inc.2014—

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 KPT devices

KPT Calibrator, Dose, Radionuclide: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.

Indications for use as stated in the FDA summary.

More from Capintec, Inc.

14 FDA decisions under this applicant name. See the company

  • 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
  • K071396CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsCapintec, Inc. · 20071 recall
  • K052595CRC 15ULTRACapintec, Inc. · 2005

Recent decisions in KPT

The KPT category page

  • 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
  • K090296Atomlab 400 and Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 and -336Biodex Medical Systems, Inc. · 20092 recalls

https://510kreport.com/device/K192199 · printed Nov 3, 2026

Cite this page

510(k) Report. “K192199: CRC PC Smart Chamber K1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192199

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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