510(k) · Cleared

Cleared

Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line

K181624510(k) TraditionalCleared Mar 22, 2019275-day reviewClass II21 CFR 868.1400

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

Oridion Medical 1987, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on Mar 22, 2019 as substantially equivalent to K010024 (Oridion Medical 1987, Ltd., 2001) and 2 other predicates after a 275-day review. Its family tree reaches back 2 generations to 1987.

Decided: Mar 22, 2019
Review: 275 days
Class: Class II
Product code: CCK
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K864902 (1987). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK864902 Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu.Salter Labs · 1987
1 generation backK013845 Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample LineOridion Medical 1987, Ltd. · 2001 · Recalled
This deviceK181624 Microstream Advance Neonatal-Infant Nasal Filter Line with O2…Oridion Medical 1987, Ltd. · 2019

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K864902	Mod. 4003 Adu., Oxy. Delive.-Oral/Nasal CO2 Cannu.	Salter Labs	1987	—
−1	K013845	Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line	Oridion Medical 1987, Ltd.	2001	2
0 (this device)	K181624	Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing…	Oridion Medical 1987, Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	2	0

FIG. 1 — Lineage of K181624, 1987–2019Source: 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 CCK? 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 CCK device

#1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K010024	O2/CO2 Nasal Filterline Summary page 4 …is device is a capnograph accessory. It is classified as follows: 21 CFR 868.1400, carbon dioxide analyzer. Predicate Devices: O2/CO2 NASAL FILTERLINE cleared under K010024 Page 2 of 6 MICROSTREAM O2/CO2 O…	Oridion Medical 1987, Ltd.	2001	3
*	K011536	Microstream O2/CO2 Oral Nasal Filterline Summary page 5 …10024 Page 2 of 6 MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE cleared under K011536 MAC-Line O2/CO2 ORAL NASAL CANNULA SAMPLE LINE cleared under K013845 Device description: Similar to their predicates, the Micr…	Oridion Medical 1987, Ltd.	2001	7
*	K013845	Modification to: Mac-Line O2/CO2 Oral Nasal Cannula Sample Line Summary page 5 …Page 2 of 6 MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE cleared under K011536 MAC-Line O2/CO2 ORAL NASAL CANNULA SAMPLE LINE cleared under K013845 Device description: Similar to their predicates, the Microstream non-intubated sampling line/Filter Line family is intended to…	Oridion Medical 1987, Ltd.	2001	2

Also cleared against K010024: 3 other devices →

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?

The line of descent spans 32 years and passes through 2 companies; a new generation was cleared every 17.3 years on median.
3 of the 4 ancestors have a recall of any class.
3 other devices also cite its predicate K010024.

How does its category compare?

All CCK devices

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

FDA decisions per year · CCK

3in 2025

2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007high 592 (2024) · low 56 (2007)2026

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

Recalls per year · CCK

1in 2022

2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007high 2,475 (2022) · low 7 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	5	56	0	7
2008	3	248	1	20
2009	3	101	19	21
2010	3	125	4	12
2011	2	—	14	18
2012	7	150	3	13
2013	4	132	2 (1)	28
2014	9	166	0	51
2015	5	105	1	114
2016	2	—	0	88
2017	5	134	0	58
2018	6	296	5	63
2019	7	261	7 (7)	141
2020	4	188	1	2,302
2021	4	227	0	2,272
2022	3	226	1	2,475
2023	4	555	0	1,637
2024	3	592	0	1,216
2025	3	169	0	1,259
2026	3	224	0	—

What is it indicated for?

Used to conduct a sample of the subject’s breathing to a gas measurement device (capnograph) while simultaneously administering supplemental oxygen projected near the nose and mouth for inhalation. The device is to be used with monitors using Microstream™ technology.

Used whenever the physician needs to collect a sample of the patient's breathing to measure CO2 with a capnograph while simultaneously administering supplemental oxygen near the nose and mouth for inhalation.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181624 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181624: Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181624

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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