510(k) Report

510(k) · Cleared

Cleared

Chrono-Log Whole Blood Lumi-Aggregometer, Model 700

K050265510(k) TraditionalCleared Oct 14, 2005252-day reviewClass II21 CFR 864.5700

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

Chrono-Log Corp. · JOZ System, Automated Platelet Aggregation

Cleared on Oct 14, 2005 as substantially equivalent to K830749 (Chrono-Log Corp., 1983) and 2 other predicates after a 252-day review. Its family tree reaches back 3 generations to 1983. 2 later devices descend from it.

Decided
Oct 14, 2005
Review
252 days
Class
Class II
Product code
JOZ
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K830749 (1983). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1985: 1 other ancestor1996: 1 other ancestor2012: 1 descendant cleared2016: 1 descendant clearedK830749 · Platelet Aggregometer · Chrono-Log Corp. · 1983K962426 · Chrono-Log Whole Blood Aggregometer (Wba) 591/592 · Chrono-Log Corp. · 1996K032951 · Chrono-Log Whole Blood Aggregometer, Models 591A and 592A · Chrono-Log Corp. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 2 descendants K032951 · Chrono-Log Whole Blood Aggregometer, Models 591A and 592A · Chrono-Log Corp. · 2004K962426 · Chrono-Log Whole Blood Aggregometer (Wba) 591/592 · Chrono-Log Corp. · 1996K830749 · Platelet Aggregometer · Chrono-Log Corp. · 19830
  1. Root · 3 generations backK830749 Platelet AggregometerChrono-Log Corp. · 1983
  2. 2 generations backK962426 Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
  3. 1 generation backK032951 Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
  4. This deviceK050265 Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp. · 2005
  5. Descendant · cites it directly · 0 of its ownK161329 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet…Chrono-Log Corp. · 2016
  6. Descendant · cites it directly · 0 of its ownK103555 Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016 · cites it directly0descendants
  • K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH · 2012 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K830749Platelet AggregometerChrono-Log Corp.1983—
−2K962426Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp.1996—
−1K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp.2004—
0 (this device)K050265Chrono-Log Whole Blood Lumi-Aggregometer, Model 700Chrono-Log Corp.2005—
+1K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer…Chrono-Log Corp.2016—
+1K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
199610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201610
FIG. 1 — Lineage of K050265, 1983–2016Source: 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 JOZ? 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 JOZ device

  1. #1 K191364 T-TAS 01 Total Thrombus-formation Analysis…score -0.6 · 3 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

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
*K830749Platelet Aggregometer
Summary page 1
…application, we have found the Chrono-iog Model 700 Whole Blood Lumi-Aggregonmeter to be substantially equivalent to Chrono-log Model 560 Whole Blood Lumi-Aggregometer (K830749) with AGGRO/L1NK Interface (K851025). 11.1I Device Description: The Chrono-log Model 700 Aggregomneter measures platelet fhin…
Chrono-Log Corp.1983—
*K851025Aggro/Link Computer Interface
Summary page 1
…no-iog Model 700 Whole Blood Lumi-Aggregonmeter to be substantially equivalent to Chrono-log Model 560 Whole Blood Lumi-Aggregometer (K830749) with AGGRO/L1NK Interface (K851025). 11.1I Device Description: The Chrono-log Model 700 Aggregomneter measures platelet fhinction on patient samples using elec…
Chrono-Log Corp.1985—
*K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592A
Summary page 2
…o-log Corp. The Model 700 has the ability to use the Chrono-log Disposable electrodes for which we demonstrate substantial equivalency to the Chrono-log Model 591A1592A (K032951) also currently in commercial distribution by Chrono-log Corporation. The Model 700 Aggregometer uses many of the same parts as…
Chrono-Log Corp.2004—

Also cleared against K830749: 8 other devices →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp.20160
K103555Multiplate 5.0 AggregometerVerum Diagnostica GmbH20120

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?

  • The line of descent spans 22 years and passes through 1 company; a new generation was cleared every 7.4 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K161329 (Chrono-Log Corp., 2016) has gone furthest, with 0 descendants of its own.
  • 8 other devices also cite its predicate K830749.

How does its category compare?

All JOZ devices

JOZ System, Automated Platelet Aggregation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JOZ

1in 2020

2012: 12013: 12015: 22016: 12017: 12019: 12020: 1
2007high 2 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JOZ

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

Recalls per year · JOZ

1in 2025

2013: 12024: 12025: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · JOZ

3in 2025

2010: 12012: 12013: 12014: 12017: 12018: 252019: 92020: 22021: 22022: 162024: 12025: 3
2007high 25 (2018) · low 0 (2007)2025

MAUDE reports naming product code JOZ, 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—01
20110—00
20121—01
20131—11
20140—01
20152—00
20161—00
20171—01
20180—025
20191—09
20201—02
20210—02
20220—016
20230—00
20240—11
20250—13
20260—0—

What is it indicated for?

For in-vitro diagnostic use for measuring platelet aggregation and ATP secretion in whole blood or platelet rich plasma.

Indications for use as stated in the FDA summary.

Also cleared against K830749

8 other devices cite the same predicate.

  • K051231Verifynow-P2Y12 AssayAccumetrics, Inc. · 20053 recalls
  • K042423Verifynow-Aspirin AssayAccumetrics, Inc. · 2004
  • K012701Ultegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc. · 20021 recall
  • K013596Modification to Ultegra System Rapid Platelet Function Assay - Trap (Rpfa-Trap)Accumetrics, Inc. · 20022 recalls
  • K992531Ultegra System Analyzer, Ultegra System Rpfa-Trap Test Cartidges, Ultegra System Rpfa-Trap Level One QC…Accumetrics, Inc. · 19993 recalls
  • K990398PlateletworksArray Medical, Inc. · 1999

More from Chrono-Log Corp.

16 FDA decisions under this applicant name. See the company

  • K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016
  • K032951Chrono-Log Whole Blood Aggregometer, Models 591A and 592AChrono-Log Corp. · 2004
  • K962426Chrono-Log Whole Blood Aggregometer (Wba) 591/592Chrono-Log Corp. · 1996
  • K945414Ristocetin Cofactor Assay KitChrono-Log Corp. · 1995
  • K940792Aggro/Link VW Cofactor SoftwareChrono-Log Corp. · 1994

Recent decisions in JOZ

The JOZ category page

  • K191364T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set…Fujimori Kogyo, Co., Ltd. · 2020
  • K181777AggreGuide A-100 ADPAggredyne, Inc. · 20191 recall
  • K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentAggredyne, Inc. · 20171 recall
  • K161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channelChrono-Log Corp. · 2016
  • K141427Accumetrics,Inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc. · 20152 recalls

https://510kreport.com/device/K050265 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050265: Chrono-Log Whole Blood Lumi-Aggregometer, Model 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050265

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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