510(k) Report

510(k) · Cleared

Cleared

Thromboscreen

K820450510(k) TraditionalCleared Mar 26, 198236-day reviewClass II21 CFR 864.7925

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

Pacific Hemostasis · GIT Reagent & Control, Partial Thromboplastin Time

Cleared on Mar 26, 1982 after a 36-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 26, 1982
Review
36 days
Class
Class II
Product code
GIT
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1999: 1 descendant cleared2001: 1 descendant cleared2003: 1 descendant cleared19801990200020102020
  1. This deviceK820450 ThromboscreenPacific Hemostasis · 1982
  2. Descendant · cites it directly · 3 of its ownK964963 Lyphochek Coagulation ControlBio-Rad · 1997
  3. Descendant · 2 generations on · 2 of its ownK990858 Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad · 1999
  4. Descendant · 3 generations on · 1 of its ownK012722 Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level…Bio-Rad · 2001
  5. Descendant · 4 generations on · 0 of its ownK032611 Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K964963Lyphochek Coagulation ControlBio-Rad · 1997 · cites it directly3descendants
  • K990858Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad · 1999 · 2 generations on2descendants
  • K012722Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2, Lyphochek…Bio-Rad · 2001 · 3 generations on1descendant
  • K032611Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad · 2003 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K820450ThromboscreenPacific Hemostasis1982—
+1K964963Lyphochek Coagulation ControlBio-Rad1997—
+2K990858Lypochek Coagulation Control, Model Nos. 787, 788, 789Bio-Rad1999—
+3K012722Lyphochek Coagulation Control Level 1, Lyphochek Coagulation Level 2…Bio-Rad2001—
+4K032611Lyphochek Coagulation Control, Level 4, Model 743Bio-Rad2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200110
200310
FIG. 1 — Lineage of K820450, 1982–2003Source: 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.

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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? (4)

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

NumberDeviceApplicantDecidedDescendants
K964963Lyphochek Coagulation ControlBio-Rad19973

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, K964963 (Bio-Rad, 1997) has gone furthest, with 3 descendants of its own.

How does its category compare?

All GIT devices

GIT Reagent & Control, Partial Thromboplastin Time: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIT

FDA has decided no GIT device since 2007.

Median 510(k) review, days · GIT

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

Recalls per year · GIT

No recall names GIT since 2007.

Adverse event reports per year · GIT

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code GIT, 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—02
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Pacific Hemostasis

29 FDA decisions under this applicant name. See the company

  • K000679Thrombostrate Control PlasmasPacific Hemostasis · 2000
  • K994100Pacific Hemostasis Thromboplastin DPacific Hemostasis · 20002 recalls
  • K992130Pacific Hemostasis Thromboscreen 400CPacific Hemostasis · 1999
  • K992279Heparin Control Plasma Level 2Pacific Hemostasis · 1999
  • K992278Heparin Control Plasma Level 1Pacific Hemostasis · 1999

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  • K890051Biotrack Aptt ControlsBiotrack, Inc. · 1989
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https://510kreport.com/device/K820450 · printed Nov 6, 2026

Cite this page

510(k) Report. “K820450: Thromboscreen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K820450

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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