510(k) Report

510(k) · Cleared

Cleared

Bioclot Protein S

K955738510(k) TraditionalCleared Feb 29, 199676-day reviewClass II21 CFR 864.7290

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

Medical Diagnostic Technologies, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency

Cleared on Feb 29, 1996 after a 76-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 29, 1996
Review
76 days
Class
Class II
Product code
GGP
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2001: 1 descendant cleared1995200020052010201520202025
  1. This deviceK955738 Bioclot Protein SMedical Diagnostic Technologies, Inc. · 1996
  2. Descendant · cites it directly · 0 of its ownK012386 Acticlot Protein S, Model 843LAmerican Diagnostica, Inc. · 2001

Most influential descendants

Showing 1 of 1 · See all
  • K012386Acticlot Protein S, Model 843LAmerican Diagnostica, Inc. · 2001 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K955738Bioclot Protein SMedical Diagnostic Technologies, Inc.1996—
+1K012386Acticlot Protein S, Model 843LAmerican Diagnostica, Inc.2001—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
FIG. 1 — Lineage of K955738, 1996–2001Source: 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 GGP? 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 GGP device

  1. #1 K251440 CRYOcheck Chromogenic Factor VIIIscore 10.5 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K012386Acticlot Protein S, Model 843LAmerican Diagnostica, Inc.20010

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, K012386 (American Diagnostica, Inc., 2001) has gone furthest, with 0 descendants of its own.

How does its category compare?

All GGP devices

GGP Test, Qualitative And Quantitative Factor Deficiency: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GGP

1in 2025

2007: 32008: 22009: 12011: 12014: 12018: 12019: 12020: 22022: 22023: 22025: 1
2007high 3 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGP

153in 2007

2007: 153 days median
2007high 153 (2007)2026

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

Recalls per year · GGP

1in 2017

2007: 22010: 12012: 22015: 22017: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

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

Adverse event reports per year · GGP

3in 2025

2012: 42014: 12015: 12017: 32018: 32019: 12021: 22022: 42025: 3
2007high 4 (2012) · low 0 (2007)2025

MAUDE reports naming product code GGP, 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
2007315320
20082—00
20091—00
20100—10
20111—00
20120—24
20130—00
20141—01
20150—21
20160—00
20170—13
20181—03
20191—01
20202—00
20210—02
20222—04
20232—00
20240—00
20251—03
20260—1—

More from Medical Diagnostic Technologies, Inc.

57 FDA decisions under this applicant name. See the company

  • K062229CTC Workstation, Model 2200Medical Diagnostic Technologies, Inc. · 2006
  • K972209Spectrolyse Heparin (Anti-Iia)Medical Diagnostic Technologies, Inc. · 1997
  • K963106Chromolize Pai-1 KitMedical Diagnostic Technologies, Inc. · 1996
  • K960871Spectrolyse Antithrombin Iii (Anti-XA)Medical Diagnostic Technologies, Inc. · 1996
  • K962489Chromolize Tpa Assay KitMedical Diagnostic Technologies, Inc. · 1996

Recent decisions in GGP

The GGP category page

  • K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc. · 2025
  • K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory Company · 2023
  • K220728vWF AgSiemens Healthcare Diagnostics Products GmbH · 2023
  • K214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc. · 2022
  • K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO · 2022

https://510kreport.com/device/K955738 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955738: Bioclot Protein S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955738

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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