510(k) · Cleared

Cleared

Iscalert Sensor System

K071165510(k) TraditionalCleared Nov 7, 2007195-day reviewClass II21 CFR 868.1150

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

Alertis Medical AS · CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

Cleared on Nov 7, 2007 as substantially equivalent to K953893 (Biomedical Sensors, Inc., 1997) after a 195-day review. Its family tree reaches back 1 generation to 1997.

Decided: Nov 7, 2007
Review: 195 days
Class: Class II
Product code: CCC
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K953893 (1997). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK953893 Paratrend 7 Intravascular Blood Gas Monitoring SystemBiomedical Sensors, Inc. · 1997
This deviceK071165 Iscalert Sensor SystemAlertis Medical AS · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K953893	Paratrend 7 Intravascular Blood Gas Monitoring System	Biomedical Sensors, Inc.	1997	—
0 (this device)	K071165	Iscalert Sensor System	Alertis Medical AS	2007	—

FIG. 1 — Lineage of K071165, 1997–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 CCC? 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? (2)

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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
Kept off the family tree	K980308	FDA’s K980308 is Echotech 3D Freescan Our reading of the summary gave K980308, FDA’s number for Echotech 3D Freescan (Echotech 3D Imaging Systems GmbH). Its FDA name has none of the distinctive words the summary uses for the device it names, “Neurotrend Cerebral Tissue Monitoring System”. Kept off the family tree. Summary page 1 …Code: GWM Equivalent Device Identification: The IscAlert Sensor System is substantially equivalent in function to the NeurotrendrTM Cerebral Tissue Monitoring System (K980308). The IscAlert sensing technology is substantially equivalent to the Paratrend 7TM Intravascular Blood Gas Monitoring System (K95…	Echotech 3D Imaging Systems GmbH	1998	—
*	K953893	Paratrend 7 Intravascular Blood Gas Monitoring System Summary page 1 …Cerebral Tissue Monitoring System (K980308). The IscAlert sensing technology is substantially equivalent to the Paratrend 7TM Intravascular Blood Gas Monitoring System (K953893). The company provided performance data demonstrating the safety and efficacy of the Sensor System for the intended use of measur…	Biomedical Sensors, Inc.	1997	—

Also cleared against K953893: 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 no recall.
1 other device also cites its predicate K953893.

How does its category compare?

All CCC devices

CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · CCC

1in 2007

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCC

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

Recalls per year · CCC

No recall names CCC since 2007.

Adverse event reports per year · CCC

2in 2007

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code CCC, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	2
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The IscAlertTM sensor system measures the partial pressure of carbon dioxide in peripheral tissue, such as forearm muscle tissue, where the sensor is inserted. The system is intended for monitoring trends in this parameter as an adjunct in the evaluation of the perfusion status of tissue in patients at risk of developing ischemia. IscAlert values are relative within an individual and should not be used as the sole basis for decisions as to diagnosis or therapy.

The IscAlertTM sensor system should not be used in peripheral brain tissue, intra cranial tissue, all organ tissues including cardiac and kidney, and other peripheral muscle tissues other than forearm muscle.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K071165 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071165: Iscalert Sensor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071165

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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