510(k) Report

510(k) · Cleared

Cleared

Stat Profile Ultra F,G,H,I,J,K, and L Analyzers

K981426510(k) TraditionalCleared May 12, 199826-day reviewClass II21 CFR 864.5600

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

Nova Biomedical Corp. · GKF Instrument, Hematocrit, Automated

Cleared on May 12, 1998 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.

Decided
May 12, 1998
Review
26 days
Class
Class II
Product code
GKF
Recalls
None
Predicates
0

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

Descendants, by year cleared 1999: 1 descendant cleared2013: 1 descendant cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK981426 Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersNova Biomedical Corp. · 1998
  2. Descendant · cites it directly · 2 of its ownK993837 Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999
  3. Descendant · 2 generations on · 1 of its ownK131126 Opti Cca-TS2Opti Medical Systems, Inc. · 2013
  4. Descendant · 3 generations on · 0 of its ownK200986 OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021

Most influential descendants

Showing 3 of 3 · See all
  • K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp. · 1999 · cites it directly2descendants
  • K131126Opti Cca-TS2Opti Medical Systems, Inc. · 2013 · 2 generations on1descendant
  • K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981426Stat Profile Ultra F,G,H,I,J,K, and L AnalyzersNova Biomedical Corp.1998—
+1K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.1999—
+2K131126Opti Cca-TS2Opti Medical Systems, Inc.2013—
+3K200986OPTI® B-Lac CassetteOpti Medical Systems, Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
201310
202110
FIG. 1 — Lineage of K981426, 1998–2021Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GKF? 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
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K993837Avl Opti Critical Care AnalyzerAvl Scientific Corp.19992

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, K993837 (Avl Scientific Corp., 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All GKF devices

GKF Instrument, Hematocrit, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GKF

1in 2016

2016: 1
2007high 1 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKF

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

Recalls per year · GKF

No recall names GKF since 2007.

Adverse event reports per year · GKF

2in 2017

2009: 22010: 12017: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code GKF, 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—02
20100—01
20110—00
20120—00
20130—00
20140—00
20150—00
20161—00
20170—02
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Nova Biomedical Corp.

89 FDA decisions under this applicant name. See the company

  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K101633Nova Max Plus Glocose and B-Ketone Control Solution-Mid, HighNova Biomedical Corp. · 2010
  • K091547Nova Max Plus Blood Glucose and B-Ketone Monitor System, Nova Max Plus B-Ketone Control Solutions, Nova Max…Nova Biomedical Corp. · 201010 Class I recalls
  • K070960Nova Statstrip Xpress Glucose Hospital Meter SystemNova Biomedical Corp. · 20071 recall
  • K070255Nova Max Blood Glucose Monitor System, 90001,90002Nova Biomedical Corp. · 2007

Recent decisions in GKF

The GKF category page

  • K160415GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin…Instrumentation Laboratory CO · 2016
  • K983551Crit-Scan II MonitorIn-Line Diagnostics Corp. · 1999
  • K981427Stat Profile M AnalyzerNova Biomedical Corp. · 19981 recall
  • K981425Stat Profile Ultra a, B, C, D, and E AnalyzersNova Biomedical Corp. · 1998
  • K953519Microspin 24Vulcon Technologies · 1995

https://510kreport.com/device/K981426 · printed Nov 5, 2026

Cite this page

510(k) Report. “K981426: Stat Profile Ultra F,G,H,I,J,K, and L Analyzers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981426

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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