510(k) · Cleared
ClearedClearLine IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clearline MD · OKL Intravascular Administration Set, Automated Air Removal System
Cleared on Jan 25, 2018 as substantially equivalent to DEN080009 (Anesthesia Safety Products, LLC, 2014) after a 210-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jan 25, 2018
- Review
- 210 days
- Class
- Class II
- Product code
- OKL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN080009 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backDEN080009 AirpurgeAnesthesia Safety Products, LLC · 2014
- This deviceK171954 ClearLine IVClearline MD · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN080009 | Airpurge | Anesthesia Safety Products, LLC | 2014 | — |
| 0 (this device) | K171954 | ClearLine IV | Clearline MD | 2018 | — |
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 OKL? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN080009 | AirpurgeSummary page 4…Product Code: OKL Review Panel: General Hospital Class: II E. Predicate Device(s): DEN080009, AirPurge™ System F. Summary Device Description: The ClearLine IV™ is a modification to the predecessor device, the AirP… | 2014 |
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.
How does its category compare?
All OKL devicesOKL Intravascular Administration Set, Automated Air Removal System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OKL
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OKL
Too few OKL 510(k)s in any year since 2007 to give a median.
Recalls per year · OKL
No recall names OKL since 2007.
Adverse event reports per year · OKL
No MAUDE report names OKL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ClearLine IV™ is intended for detection and automatic removal of air in intravenous (IV) lines during administration of IV solutions, blood, and blood products. It is indicated for use in critical care areas such as the operating room (OR), post-anesthesia care unit (PACU), and intensive care unit (ICU). ClearLine IV™ is placed between the patient and the IV source and can be used with or without fluid warmers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171954 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171954: ClearLine IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171954
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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