510(k) Report

510(k) · Cleared

Cleared

Aia-Pack CPR Assay

K951848510(k) TraditionalCleared Feb 13, 1996298-day reviewClass I21 CFR 862.1135

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

Tosoh Medics, Inc. · JKD Radioimmunoassay, C-Peptides Of Proinsulin

Cleared on Feb 13, 1996 after a 298-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 13, 1996
Review
298 days
Class
Class I
Product code
JKD
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2014: 1 descendant cleared2008: 1 descendant cleared1995200020052010201520202025
  1. This deviceK951848 Aia-Pack CPR AssayTosoh Medics, Inc. · 1996
  2. Descendant · cites it directly · 1 of its ownK021532 Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp. · 2002
  3. Descendant · cites it directly · 0 of its ownK140648 ST Aia-Pack C-Peptide II Calibrator SetTosoh Bioscience, Inc. · 2014
  4. Descendant · 2 generations on · 0 of its ownK082141 Architect C-Peptide Calibrators, and Architect C-Peptide Controls…Biokit, S.A. · 2008

Most influential descendants

Showing 3 of 3 · See all
  • K021532Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp. · 2002 · cites it directly1descendant
  • K140648ST Aia-Pack C-Peptide II Calibrator SetTosoh Bioscience, Inc. · 2014 · cites it directly0descendants
  • K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models 3L53-01, 3L53-10Biokit, S.A. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K951848Aia-Pack CPR AssayTosoh Medics, Inc.1996—
+1K021532Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp.2002—
+1K140648ST Aia-Pack C-Peptide II Calibrator SetTosoh Bioscience, Inc.2014—
+2K082141Architect C-Peptide Calibrators, and Architect C-Peptide Controls, Models…Biokit, S.A.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200810
201410
FIG. 1 — Lineage of K951848, 1996–2014Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JKD? 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? (3)

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

NumberDeviceApplicantDecidedDescendants
K021532Advia Centaur and Acs:180 C-Peptide CalibratorBayer Diagnostics Corp.20021
K140648ST Aia-Pack C-Peptide II Calibrator SetTosoh Bioscience, Inc.20140

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, K021532 (Bayer Diagnostics Corp., 2002) has gone furthest, with 1 descendant of its own.

How does its category compare?

All JKD devices

JKD Radioimmunoassay, C-Peptides Of Proinsulin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JKD

FDA has decided no JKD device since 2007.

Median 510(k) review, days · JKD

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

Recalls per year · JKD

1in 2021

2011: 12021: 1
2007high 1 (2011) · low 0 (2007)2026

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

Adverse event reports per year · JKD

3in 2025

2011: 132020: 12021: 12022: 12025: 3
2007high 13 (2011) · low 0 (2007)2025

MAUDE reports naming product code JKD, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—113
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—01
20210—11
20220—01
20230—00
20240—00
20250—03
20260—0—

More from Tosoh Medics, Inc.

41 FDA decisions under this applicant name. See the company

  • K023893ST Aia-Pack Cea Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023894ST Aia-Pack Afp Enzyme ImmunoassayTosoh Medics, Inc. · 20021 recall
  • K023091ST Aia-Pack Testosterone AssayTosoh Medics, Inc. · 20023 recalls
  • K023891ST Aia-Pack CA 125 Enzyme ImmunoassayTosoh Medics, Inc. · 2002
  • K020489G7 Automated HPLC Analyzer, Beta-Thalassemia ModeTosoh Medics, Inc. · 20022 recalls

Recent decisions in JKD

The JKD category page

  • K943767Immulite C-PeptideDiagnostic Products Corp. · 1995
  • K896420DSL C-Peptide Ria (DSL #7000)Diagnostic Systems Laboratories, Inc. · 1990
  • K854066Double Antibody C-Peptide Ria KitDiagnostic Products Corp. · 1985
  • K842267C-Pep-Ria-100Institut National Des Radioelements · 1984
  • K833396C-Peptide Radioimmunoassay Test KitSerono Diagnostics, Inc. · 1984

https://510kreport.com/device/K951848 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951848: Aia-Pack CPR Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951848

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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