510(k) Report

510(k) · Cleared

Recalled · Class II · 2011

I-Stat Portable Clinical Analyzer, Model 300

K001387510(k) TraditionalCleared Oct 5, 2000156-day reviewClass II21 CFR 862.1345Recalls 13

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

I-Stat Corp. · CGA Glucose Oxidase, Glucose

Cleared on Oct 5, 2000 after a 156-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it. It has been recalled 13 times.

Decided
Oct 5, 2000
Review
156 days
Class
Class II
Product code
CGA
Recalls
13
Predicates
0

18 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2011: 1 descendant cleared2010: 2 descendants cleared2009: 1 descendant cleared2006: 1 descendant cleared2020: 4 descendants cleared2017: 2 descendants cleared2016: 1 descendant cleared2021: 1 descendant cleared2023: 3 descendants cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK001387 I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. · 2000
  2. Descendant · cites it directly · 8 of its ownK103195 I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011
  3. Descendant · cites it directly · 7 of its ownK061597 Epoc Blood Analysis SystemEpocal, Inc. · 2006 · Recalled
  4. Descendant · 2 generations on · 5 of its ownK191360 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020
  5. Descendant · 2 generations on · 5 of its ownK163342 i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017
  6. Descendant · 3 generations on · 4 of its ownK183680 i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2006: 12009: 12010: 22011: 12012: 12016: 12017: 22020: 42021: 12023: 32026: 1
2006high 4 (2020) · low 0 (2007)2026

Most influential descendants

Showing 5 of 18 · See all
  • K103195I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc. · 2011 · cites it directly8descendants
  • K061597Epoc Blood Analysis SystemEpocal, Inc. · 2006 · cites it directly7descendants
  • K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 2 generations on5descendants
  • K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories · 2017 · 2 generations on5descendants
  • K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2020 · 3 generations on4descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001387I-Stat Portable Clinical Analyzer, Model 300I-Stat Corp.2000—
+1K103195I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc.2011—
+1K061597Epoc Blood Analysis SystemEpocal, Inc.20062
+2K191360i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020—
+2K163342i-STAT Hematocrit test with i-STAT Alinity SystemAbbott Laboratories2017—
+3K183680i-STAT CHEM8+ cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200910
201020
201110
201210
201610
201720
202040
202110
202330
202610
FIG. 1 — Lineage of K001387, 2000–2026Source: 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 CGA? 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 CGA device

  1. #1 K252488 ABL90 FLEX PLUS Systemscore 12.8 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (18)

See all 18

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103195I-Stat 1 Wireless AnalyzerAbbott Point of Care, Inc.20118
K061597Epoc Blood Analysis SystemEpocal, Inc.20067
K093297Epoc Bgem, Epoc Reader, Epoc Host, Epoc Care-Fill Capillary TubeEpocal, Inc.20102
K113726Epoc Chloride Test and Epoc Creatinine TestEpocal, Inc.20121
K092849Blood Collection Tube Samples for Use with Point of Care Blood AnalyzerEpocal, Inc.20101
K090109Blood Gas, Electrolyte and Metabolite Test CardEpocal, Inc.20090

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Sep 8, 2011Class IIZ-1973-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011Class IIZ-1975-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011Class IIZ-1974-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011Class IIZ-1976-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011Class IIZ-1978-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 8, 2011Class IIZ-1977-2012Device DesignSome i-Stat Analyzers become uncomfortably hot to touch in the are of the battery. This is a recall extension.
Sep 20, 2010Not classifiedZ-0598-2011Otheri-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Sep 20, 2010Not classifiedZ-0597-2011Otheri-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component.
Aug 20, 2010Not classifiedZ-2462-2010Device DesignReliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer.
Nov 6, 2009Not classifiedZ-1133-2010Component design/selectionSome Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
Sep 29, 2009Not classifiedZ-0865-2010Software designAbbott Point of Care has determined that it is possible under certain circumstances that some test records could have their status update messages mis-matched with another record, resulting in the incorrect patient name, order number of…
Sep 9, 2009Not classifiedZ-0812-2010Labeling mix-upsThe storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification.
Apr 22, 2009Not classifiedZ-2328-2009Nonconforming Material/ComponentIt appears that the rechargeable battery pack is overheating with or without the presence of smoke.

The 5 latest of 13 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K103195 (Abbott Point of Care, Inc., 2011) has gone furthest, with 8 descendants of its own.

How does its category compare?

All CGA devices

CGA Glucose Oxidase, Glucose: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGA

2in 2024

2007: 72008: 62009: 102010: 82011: 92012: 102013: 32014: 52015: 42016: 42017: 22018: 22019: 22020: 22021: 12022: 12023: 42024: 22026 (partial year): 1
2007high 10 (2009) · low 0 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGA

249in 2023

2007: 122 days median2008: 56 days median2009: 155 days median2010: 122 days median2011: 217 days median2012: 123 days median2013: 441 days median2014: 265 days median2015: 150 days median2016: 157 days median2023: 249 days median
2007high 441 (2013) · low 56 (2008)2026

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

Recalls per year · CGA

3in 2023

2007: 22008: 22009: 42010: 62011: 32013: 32014: 22015: 6, 2 Class I2016: 22019: 12023: 3
2007high 6 (2010) · low 0 (2012)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · CGA

59in 2025

2007: 292008: 372009: 752010: 1722011: 4232012: 2332013: 1722014: 1222015: 1552016: 362017: 922018: 692019: 1162020: 682021: 482022: 2722023: 1,1412024: 2662025: 59
2007high 1,141 (2023) · low 29 (2007)2025

MAUDE reports naming product code CGA, 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
20077122229
2008656237
200910155475
201081226172
201192173423
2012101230233
201334413172
201452652122
201541506 (2)155
20164157236
20172—092
20182—069
20192—1116
20202—068
20211—048
20221—0272
2023424931,141
20242—0266
20250—059
20261—0—

More from I-Stat Corp.

14 FDA decisions under this applicant name. See the company

  • K012478Modification to: I-Stat Portable Clinical AnalyzerI-Stat Corp. · 2001
  • K011478I-Stat SystemI-Stat Corp. · 2001
  • K001154I-Stat Model 200 Portable Clinical AnalyzerI-Stat Corp. · 20004 recalls
  • K992571I-Stat SystemI-Stat Corp. · 20004 recalls
  • K982071I-Stat Lactate TestI-Stat Corp. · 19981 recall

Recent decisions in CGA

The CGA category page

  • K252488ABL90 FLEX PLUS SystemRadiometer Medicals Aps · 2026
  • K210933YSI 2900C Biochemistry AnalyzerYsi, Inc. · 2024
  • K220328EasyStat 300Medica Corporation · 2024
  • K223179Cholestech LDX ™ SystemAlere San Diego, Inc. · 2023
  • K223755i-STAT G cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc. · 2023

https://510kreport.com/device/K001387 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001387: I-Stat Portable Clinical Analyzer, Model 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001387

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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