510(k) · Cleared

Cleared

Hemochron Response/System

K030818510(k) SpecialCleared Apr 2, 200319-day reviewClass II21 CFR 864.5425

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

International Technidyne Corp. · JPA System, Multipurpose For In Vitro Coagulation Studies

Cleared on Apr 2, 2003 as substantially equivalent to K983475 (International Technidyne Corp., 1999) after a 19-day review. Its family tree reaches back 2 generations to 1993.

Decided: Apr 2, 2003
Review: 19 days
Class: Class II
Product code: JPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K930068 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK930068 Hemochron Model 8000/Factor VI Premier CoagulationTechnidyne Corp. · 1993
1 generation backK983475 Hemochron ResponseInternational Technidyne Corp. · 1999 · Recalled
This deviceK030818 Hemochron Response/SystemInternational Technidyne Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K930068	Hemochron Model 8000/Factor VI Premier Coagulation	Technidyne Corp.	1993	—
−1	K983475	Hemochron Response	International Technidyne Corp.	1999	1
0 (this device)	K030818	Hemochron Response/System	International Technidyne Corp.	2003	—

FIG. 1 — Lineage of K030818, 1993–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JPA? 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 JPA device

#1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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.

Type	Number	Device	Applicant	Decided	Recalls
*	K983475	Hemochron Response Summary page 1 …tem Product Name: HEMOCHRONB Response InstrumentISystem Predicate Device HEMOCHRONB Response (K983475) Device Description The Hemochron Response instrument/system described herein i…	International Technidyne Corp.	1999	1

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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
1 of the 2 ancestors has a recall of any class.

How does its category compare?

All JPA devices

JPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JPA

3in 2025

2007high 6 (2009) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JPA

30in 2025

2007high 506 (2023) · low 30 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JPA

1in 2020

2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JPA

11in 2025

2007high 1,744 (2007) · low 6 (2016)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	1,744
2008	2	—	0	918
2009	6	91	0	1,363
2010	1	—	6	727
2011	1	—	4	161
2012	0	—	1	52
2013	1	—	0	43
2014	0	—	0	48
2015	2	—	0	45
2016	6	114	3	6
2017	4	117	0	15
2018	1	—	0	39
2019	3	175	0	27
2020	0	—	1	18
2021	1	—	0	7
2022	1	—	0	9
2023	3	506	0	11
2024	1	—	0	8
2025	3	30	0	11
2026	1	—	1	—

What is it indicated for?

The HEMOCHRON @ Response is intended for professional use for hemostasis

management in a variety of clinical settings for the quantitative determination of an

assortment of coagulation test assays including the following HEMOCHRON Whole

Blood Coagulation Assays

Activated Clotting Time (ACT) - All HEMOCHRON types

Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types

Prothrombin Time (PT) - All HEMOCHRON types

Thrombin Time (TT)

Heparin Neutralized Thrombin Time (HNTT)

High Dose Thrombin Time (HiTT)

Fibrinogen (FIB)

Protamine Dose Assay (PDA) - All HEMOCHRON types

Heparin Response Time (HRT) - All HEMOCHRON types

Protamine Response Time (PRT) - All HEMOCHRON types

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030818 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030818: Hemochron Response/System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030818

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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