510(k) Report

510(k) · Cleared

Cleared

Thromboscreen Aptt Reagent

K891337510(k) TraditionalCleared Apr 21, 198942-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 · GFO Activated Partial Thromboplastin

Cleared on Apr 21, 1989 after a 42-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 21, 1989
Review
42 days
Class
Class II
Product code
GFO
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2002: 1 descendant cleared1990200020102020
  1. This deviceK891337 Thromboscreen Aptt ReagentPacific Hemostasis · 1989
  2. Descendant · cites it directly · 0 of its ownK060968 Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium…Wortham Laboratories, Inc. · 2007
  3. Descendant · cites it directly · 0 of its ownK022021 Vital Scientific Aptt, Aptt & Quikcoag ApttVital Scientific N.V. · 2002

Most influential descendants

Showing 2 of 2 · See all
  • K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc. · 2007 · cites it directly0descendants
  • K022021Vital Scientific Aptt, Aptt & Quikcoag ApttVital Scientific N.V. · 2002 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K891337Thromboscreen Aptt ReagentPacific Hemostasis1989—
+1K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride…Wortham Laboratories, Inc.2007—
+1K022021Vital Scientific Aptt, Aptt & Quikcoag ApttVital Scientific N.V.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200710
FIG. 1 — Lineage of K891337, 1989–2007Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GFO? 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 GFO device

  1. #1 K253957 HemosIL Silica Clotting Timescore 11.6 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

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? (2)

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

NumberDeviceApplicantDecidedDescendants
K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M…Wortham Laboratories, Inc.20070
K022021Vital Scientific Aptt, Aptt & Quikcoag ApttVital Scientific N.V.20020

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, K060968 (Wortham Laboratories, Inc., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GFO devices

GFO Activated Partial Thromboplastin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GFO

1in 2020

2016: 12020: 12026 (partial year): 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GFO

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

Recalls per year · GFO

1in 2025

2013: 12018: 22025: 1
2007high 2 (2018) · low 0 (2007)2026

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

Adverse event reports per year · GFO

14in 2025

2011: 72013: 32014: 22015: 22016: 32017: 192018: 42019: 12021: 112023: 32024: 22025: 14
2007high 19 (2017) · low 0 (2007)2025

MAUDE reports naming product code GFO, 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—07
20120—00
20130—13
20140—02
20150—02
20161—03
20170—019
20180—24
20190—01
20201—00
20210—011
20220—00
20230—03
20240—02
20250—114
20261—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

Recent decisions in GFO

The GFO category page

  • K253957HemosIL Silica Clotting TimeInstrumentation Laboratory (IL) Co. · 2026
  • K193556Cryocheck Hex LAPrecision Biologic · 2020
  • K160445HemosIL Silica Clotting TimeInstrumentation Laboratory CO · 2016
  • K053111Sta-Cephascreen KitDiagnostica Stago, Inc. · 2006
  • K060688Hemosil SynthasilInstrumentation Laboratory CO · 20061 recall

https://510kreport.com/device/K891337 · printed Nov 4, 2026

Cite this page

510(k) Report. “K891337: Thromboscreen Aptt Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891337

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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