510(k) Report

510(k) · Cleared

Cleared

I-Stat Lactate Test/I-Sat CG4+Cartridge

K112430510(k) TraditionalCleared Dec 20, 2011118-day reviewClass I21 CFR 862.1450

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

Abbott Pont of Care, Inc. · KHP Acid, Lactic, Enzymatic Method

Cleared on Dec 20, 2011 as substantially equivalent to K982071 (I-Stat Corp., 1998) after a 118-day review. Its family tree reaches back 1 generation to 1998.

Decided
Dec 20, 2011
Review
118 days
Class
Class I
Product code
KHP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K982071 (1998). No later device cites it as a predicate yet.

K982071 · I-Stat Lactate Test · I-Stat Corp. · 1998 · recalled1995200020052010
K982071 · I-Stat Lactate Test · I-Stat Corp. · 1998 · recalled0
  1. Root · 1 generation backK982071 I-Stat Lactate TestI-Stat Corp. · 1998 · Recalled
  2. This deviceK112430 I-Stat Lactate Test/I-Sat CG4+CartridgeAbbott Pont of Care, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K982071I-Stat Lactate TestI-Stat Corp.19981
0 (this device)K112430I-Stat Lactate Test/I-Sat CG4+CartridgeAbbott Pont of Care, Inc.2011—
FIG. 1 — Lineage of K112430, 1998–2011Source: 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 KHP? 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? (1)

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
*K982071I-Stat Lactate Test
Summary page 1
…al Chemistry Product Code: KHP Performance Standards: No applicable standards Identification of the Predicate Device: i-STAT Lactate Test part of the C04± Cartridge (K982071) Indication for Use Statement The i-STAT Lactate Test is indicated for (1) the diagnosis and treatment of lactic…
I-Stat Corp.19981

Also cleared against K982071: 1 other device →

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?

  • Its one ancestor has a recall.
  • 1 other device also cites its predicate K982071.

How does its category compare?

All KHP devices

KHP Acid, Lactic, Enzymatic Method: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · KHP

1in 2013

2010: 12011: 22012: 22013: 1
2007high 2 (2011) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KHP

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

Recalls per year · KHP

3in 2016

2014: 12016: 3
2007high 3 (2016) · low 0 (2007)2026

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

Adverse event reports per year · KHP

9in 2025

2010: 22011: 22012: 32013: 122014: 192015: 122016: 412017: 92018: 122019: 102020: 62021: 32022: 72023: 32024: 132025: 9
2007high 41 (2016) · low 0 (2007)2025

MAUDE reports naming product code KHP, 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
20101—02
20112—02
20122—03
20131—012
20140—119
20150—012
20160—341
20170—09
20180—012
20190—010
20200—06
20210—03
20220—07
20230—03
20240—013
20250—09
20260—0—

What is it indicated for?

The Lactate Acid Test is indicated for (1) the diagnosis and treatment of lactic acidosis in conjunction with measurements of blood acidibase status, (2) monitoring tissue hypoxia and strenuous physical exertion, (3) diagnosis of hyperlactatemnia.

The Lactate Test, as part of the i-STAT System, is intended for the in vitro measurement of lactate in arterial, venous, or capillary whole blood.

Indications for use as stated in the FDA summary.

Also cleared against K982071

1 other device cites the same predicate.

  • K130113Piccolo Lactate Test SystemAbaxis, Inc. · 2013

Recent decisions in KHP

The KHP category page

  • K130113Piccolo Lactate Test SystemAbaxis, Inc. · 2013
  • K113216Rapidpoint 500 Blood Gas AnalyerSiemens Healthcare Diagnostics · 201212 recalls
  • K112955Nova Statstrip Lactate Hospital Meter SystemNova Biomedical Corporation · 2012
  • K100602Nova Statstrip Lactate Hospital Meter, Nova Statstrip Lactate Test StripsNova Biomedical Corp. · 2011
  • K093297Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc. · 20101 recall

https://510kreport.com/device/K112430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K112430: I-Stat Lactate Test/I-Sat CG4+Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112430

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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