510(k) Report

510(k) · Cleared

Cleared

Sendx 100 PH, Blood Gas and Electrolyte Analysis System

K973742510(k) TraditionalCleared Dec 3, 199763-day reviewClass II21 CFR 862.1170

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

Sendx Medical, Inc. · CGZ Electrode, Ion-Specific, Chloride

Cleared on Dec 3, 1997 as substantially equivalent to K903965 (Ppg Industries, Inc., 1990) and 5 other predicates after a 63-day review. Its family tree reaches back 1 generation to 1988.

Decided
Dec 3, 1997
Review
63 days
Class
Class II
Product code
CGZ
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K874832 (1988). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1992: 1 other ancestor1991: 2 other ancestors1990: 1 other ancestorK874832 · Nova Stat Profile 5 Analyzer + Quality Control · Nova Biomedical Corp. · 19881986198819901992199419961998
Other ancestors, by generation 1 generation back: 5 other ancestors K874832 · Nova Stat Profile 5 Analyzer + Quality Control · Nova Biomedical Corp. · 19880
  1. Root · 1 generation backK874832 Nova Stat Profile 5 Analyzer + Quality ControlNova Biomedical Corp. · 1988
  2. This deviceK973742 Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K874832Nova Stat Profile 5 Analyzer + Quality ControlNova Biomedical Corp.1988—
0 (this device)K973742Sendx 100 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199120
199210
199410
FIG. 1 — Lineage of K973742, 1988–1997Source: 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 CGZ? 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? (6)

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
*K903965Statpal Blood Gas Monitoring System
Summary page 3
…stantially equivalent to other blood gas analyzers such as: StatPal versions were previously submitted and cleared for marketing under 510(k) document Control numbers: K903965/B K914560 K922631/B. These three StatPal versions were found by FDA to be substantially equivalent to the Mallinckrodt® GEM®-STA…
Ppg Industries, Inc.1990—
*K914560Stat Pal Sensyr Syringe Assembly for Use W/Statpal
Summary page 3
…equivalent to other blood gas analyzers such as: StatPal versions were previously submitted and cleared for marketing under 510(k) document Control numbers: K903965/B K914560 K922631/B. These three StatPal versions were found by FDA to be substantially equivalent to the Mallinckrodt® GEM®-STAT, among o…
Ppg Industries, Inc.1991—
*K922631Statpal II Blood Gas Analysis System
Summary page 3
…ent to other blood gas analyzers such as: StatPal versions were previously submitted and cleared for marketing under 510(k) document Control numbers: K903965/B K914560 K922631/B. These three StatPal versions were found by FDA to be substantially equivalent to the Mallinckrodt® GEM®-STAT, among other ins…
Ppg Industries, Inc.1992—
*K934907860 Measurment System
Summary page 3
…antially equivalent to other blood gas and electrolyte systems such as: 1) The Ciba-Corning, Corning 865 Blood Gas and Electrolyte System 510(k) Document Control number K 934907. 2) The Mallinckrodt® GEM®-PREMIER Blood Gas and Electrolyte Monitor, 510(k) Document Control number K 910305. 3) The NOVA Biom…
Ciba Corning Diagnostics Corp.1994—
*K910305Gem-Premier System
Summary page 3
…Gas and Electrolyte System 510(k) Document Control number K 934907. 2) The Mallinckrodt® GEM®-PREMIER Blood Gas and Electrolyte Monitor, 510(k) Document Control number K 910305. 3) The NOVA Biomedical, NOVA STAT Profile 5, 510(k) Document Control Number K874832. 14-004 Description The S…
Mallinckrodt Sensor Systems, Inc.1991—
*K874832Nova Stat Profile 5 Analyzer + Quality Control
Summary page 3
…dt® GEM®-PREMIER Blood Gas and Electrolyte Monitor, 510(k) Document Control number K 910305. 3) The NOVA Biomedical, NOVA STAT Profile 5, 510(k) Document Control Number K874832. 14-004 Description The SenDx 100™ system consists of the analyzer, a multi-use, disposable sensor cassette and…
Nova Biomedical Corp.1988—

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?

  • None of the 6 ancestors has a recall.

How does its category compare?

All CGZ devices

CGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CGZ

1in 2018

2007: 12008: 22016: 12017: 12018: 1
2007high 2 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CGZ

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

Recalls per year · CGZ

2in 2019

2007: 12008: 12009: 12011: 12019: 2
2007high 2 (2019) · low 0 (2010)2026

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

Adverse event reports per year · CGZ

5in 2025

2007: 42009: 12010: 72011: 52012: 302013: 422014: 102015: 22016: 12017: 22018: 192019: 32020: 32022: 52023: 92024: 62025: 5
2007high 42 (2013) · low 0 (2008)2025

MAUDE reports naming product code CGZ, 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
20071—14
20082—10
20090—11
20100—07
20110—15
20120—030
20130—042
20140—010
20150—02
20161—01
20171—02
20181—019
20190—23
20200—03
20210—00
20220—05
20230—09
20240—06
20250—05
20260—0—

What is it indicated for?

The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and hematocrit in whole blood. The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous whole blood samples. The SenDx 100™ pH, Blood Gas and…

Read the full statement (132 words)

The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is intended to

measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride, ionized calcium and

hematocrit in whole blood.

The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care settings. It

is intended for the measurement of blood gases, electrolytes and hematocrit in arterial or venous

whole blood samples.

The SenDx 100™ pH, Blood Gas and Electrolyte Analysis System (SenDx 100™) is

intended to measure blood oxygen, carbon dioxide, pH, sodium, potassium, chloride,

ionized calcium and hematocrit in whole blood.

The SenDx 100™ system can be used in the laboratory, near patient, or in point-of-care

settings. It is intended for the measurement of blood gases, electrolytes and hematocrit

in arterial or venous whole blood samples.

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

More from Sendx Medical, Inc.

6 FDA decisions under this applicant name. See the company

  • K151639ABL80 FLEX and ABL80 FLEX CO-OXSendx Medical, Inc. · 2015
  • K151856ABL80 FLEX CO-OX with AQURE connectivitySendx Medical, Inc. · 20153 recalls
  • K080370Abl 80 CO-OX SystemSendx Medical, Inc. · 20084 recalls
  • K051804ABL80 Flex AnalyzerSendx Medical, Inc. · 20054 recalls
  • K994346Abl 77 PH, Blood Gas and Electrolyte Analysis SystemSendx Medical, Inc. · 20001 recall

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https://510kreport.com/device/K973742 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973742: Sendx 100 PH, Blood Gas and Electrolyte Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973742

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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