510(k) Report

510(k) · Cleared

Cleared

Specialty Assayed Control-1

K941737510(k) TraditionalCleared Oct 7, 1994183-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

Helena Laboratories · GIZ Plasma, Control, Normal

Cleared on Oct 7, 1994 after a 183-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 7, 1994
Review
183 days
Class
Class II
Product code
GIZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 1 descendant cleared2005: 1 descendant cleared2004: 1 descendant cleared1990200020102020
  1. This deviceK941737 Specialty Assayed Control-1Helena Laboratories · 1994
  2. Descendant · cites it directly · 2 of its ownK020878 Lyphochek Hemostasis, Models 798, 799Bio-Rad · 2002
  3. Descendant · 2 generations on · 0 of its ownK043451 Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005
  4. Descendant · 2 generations on · 0 of its ownK040275 Lyphochek Hemostasis ControlBio-Rad · 2004

Most influential descendants

Showing 3 of 3 · See all
  • K020878Lyphochek Hemostasis, Models 798, 799Bio-Rad · 2002 · cites it directly2descendants
  • K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed · 2005 · 2 generations on0descendants
  • K040275Lyphochek Hemostasis ControlBio-Rad · 2004 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K941737Specialty Assayed Control-1Helena Laboratories1994—
+1K020878Lyphochek Hemostasis, Models 798, 799Bio-Rad2002—
+2K043451Biophen Normal and Abnormal Control Plasma; Biophen Plasma CalibratorHyphen Biomed2005—
+2K040275Lyphochek Hemostasis ControlBio-Rad2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200510
FIG. 1 — Lineage of K941737, 1994–2005Source: 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 GIZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (3)

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

NumberDeviceApplicantDecidedDescendants
K020878Lyphochek Hemostasis, Models 798, 799Bio-Rad20022

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, K020878 (Bio-Rad, 2002) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GIZ devices

GIZ Plasma, Control, Normal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GIZ

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GIZ

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

Recalls per year · GIZ

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

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

Adverse event reports per year · GIZ

No MAUDE report names GIZ since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Helena Laboratories

280 FDA decisions under this applicant name. See the company

  • K131479V8 SP Normal Control, Abnormal ControlHelena Laboratories · 2013
  • K100103Specialty Assayed Control-2Helena Laboratories · 2010
  • K061991Plateletworks Arachidonic Acid, Model PW-AcaHelena Laboratories · 2007
  • K061069Spife Ife-15 Pentavalent, Model 3456, Spife Ife-9 Pentavalent Kit, Model 3457, Spift Ife-6 Pentavalent Kit…Helena Laboratories · 2006
  • K061014Actalyke QC Kit, Models Aqc-HP and Aqc-LPHelena Laboratories · 20061 recall

Recent decisions in GIZ

The GIZ category page

  • K060968Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal…Wortham Laboratories, Inc. · 2007
  • K042941Dade Behring Heparin Calibrator and ControlsDade Behring, Inc. · 2004
  • K023309Control Plasma NDade Behring, Inc. · 2002
  • K013708Reference Check, Catalog Number-RCN-10Precision Biologic · 2001
  • K003328Accuclot Control I, Model A4089Sigma Diagnostics, Inc. · 2001

https://510kreport.com/device/K941737 · printed Nov 6, 2026

Cite this page

510(k) Report. “K941737: Specialty Assayed Control-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K941737

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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