510(k) Report

510(k) · Cleared

Cleared

Factor Deficient Plasma

K961929510(k) TraditionalCleared Oct 10, 1996146-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

Universal Reagents, Inc. · GGP Test, Qualitative And Quantitative Factor Deficiency

Cleared on Oct 10, 1996 as substantially equivalent to K924394 (Behring Diagnostics, Inc., 1992) and 10 other predicates after a 146-day review. Its family tree reaches back 1 generation to 1989.

Decided
Oct 10, 1996
Review
146 days
Class
Class II
Product code
GGP
Recalls
None
Predicates
11

Its longest line of descent runs back 1 generation to K893523 (1989). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 2 other ancestors1992: 1 other ancestor1990: 1 other ancestor1989: 6 other ancestorsK893523 · Factor X Deficient Plasma · Medical Diagnostic Technologies, Inc. · 19891986198819901992199419961998
Other ancestors, by generation 1 generation back: 10 other ancestors K893523 · Factor X Deficient Plasma · Medical Diagnostic Technologies, Inc. · 19890
  1. Root · 1 generation backK893523 Factor X Deficient PlasmaMedical Diagnostic Technologies, Inc. · 1989
  2. This deviceK961929 Factor Deficient PlasmaUniversal Reagents, Inc. · 1996
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K893523Factor X Deficient PlasmaMedical Diagnostic Technologies, Inc.1989—
0 (this device)K961929Factor Deficient PlasmaUniversal Reagents, Inc.1996—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198960
199010
199210
199320
FIG. 1 — Lineage of K961929, 1989–1996Source: 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), 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 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? (11)

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
*K924394Clotting Factor V Deficient Plasma
Summary page 1
…, V, VI, Viil, IX, X, Xi, XH Factor deficient coagulation plasma Factor deficient coagulation plasma - I, V, VII, VIil, IX, X, XI, Xll Behring Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor…
Behring Diagnostics, Inc.1992—
*K924396Clotting Factor-Viii-IX-XI-Xii Deficient Plasma
Summary page 1
…, Xi, XH Factor deficient coagulation plasma Factor deficient coagulation plasma - I, V, VII, VIil, IX, X, XI, Xll Behring Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor…
Behring Diagnostics, Inc.19932
*K924400Clotting Factor-11,-Vii, -X Deficient Plasma
Summary page 1
…ion plasma Factor deficient coagulation plasma - I, V, VII, VIil, IX, X, XI, Xll Behring Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K89353…
Behring Diagnostics, Inc.1993—
*K893523Factor X Deficient Plasma
Summary page 1
…X, X, XI, Xll Behring Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536…
Medical Diagnostic Technologies, Inc.1989—
*K893524Factor IX Deficient Plasma
Summary page 1
…g Factor Deficient Plasmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133…
Medical Diagnostic Technologies, Inc.1989—
*K893525Factor Viii Deficient Plasma
Summary page 1
…asmas - K924394 - Factor V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133 - Factor Il. Factor…
Medical Diagnostic Technologies, Inc.1989—
*K893533Factor V Deficient Plasma
Summary page 1
…r V, K924396 - Factor Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133 - Factor Il. Factor deficient plasma to be…
Medical Diagnostic Technologies, Inc.1989—
*K893534Factor Xii Deficient Plasma
Summary page 1
…r Vill, IX, X1, Xl K924400 - Factor Il, VIi, X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133 - Factor Il. Factor deficient plasma to be free of antigen of…
Medical Diagnostic Technologies, Inc.1989—
*K893535Factor Vii Deficient PlasmaMedical Diagnostic Technologies, Inc.1989—
*K893536Factor XI Deficient Plasma
Summary page 1
…X and Medical Diagnostics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133 - Factor Il. Factor deficient plasma to be free of antigen of Factor Il, V, VI, VI, I X, X, X, respectively…
Medical Diagnostic Technologies, Inc.1989—
*K900133Factor II Deficient Plasma
Summary page 1
…tics Technologies - K893523 - Factor X, K893524 - Factor IX, K893525 - Factor VIII, K893533 - Factor V, K893534 - Factor XllI, K8B93535 - Factor Vi, K893536 - Factor XI, K900133 - Factor Il. Factor deficient plasma to be free of antigen of Factor Il, V, VI, VI, I X, X, X, respectively, utilized in in vitr…
Medical Diagnostic Technologies, Inc.1990—

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?

  • 1 of the 11 ancestors has a recall of any class.

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—

What is it indicated for?

Factor deficient plasma, Factor - Il, V, VII, VIII, IX, X, Xi, XIl, is a human plasma immunodepleted of the specific factor and intended for use in the quantitative determination of the specific factor levels in patients suspected of congenital or acquired deficiency of this specific coagulation protein and is performed by clotting assay. Factor Vlil is human plasma and bovine material.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Universal Reagents, Inc.

8 FDA decisions under this applicant name. See the company

  • K973143Universal Reagent Factor Xii (Twelve) Deficient PlasmaUniversal Reagents, Inc. · 1997
  • K972288Factor Deficient Plasmas - Factor IX (9)Universal Reagents, Inc. · 1997
  • K972286Factor Deficient Plasmas - Factor XI (11)Universal Reagents, Inc. · 1997
  • K970607Universal Reagent Factor Vii Deficient PlasmaUniversal Reagents, Inc. · 1997
  • K970593Universal Reagent Factor Viii Deficient PlasmaUniversal Reagents, Inc. · 1997

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/K961929 · printed Nov 4, 2026

Cite this page

510(k) Report. “K961929: Factor Deficient Plasma.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961929

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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