510(k) · Cleared
ClearedStratus Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intervene, Inc. · NPG Catheter, Infusion, Syringe
Cleared on Apr 13, 2023 as substantially equivalent to K161402 (Mercator Medsystems, Inc., 2016) after a 265-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Apr 13, 2023
- Review
- 265 days
- Class
- Class II
- Product code
- NPG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913517 (1991). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK913517 Isolate Infusion Cathetr SystemLake Region Mfg., Inc. · 1991
- 4 generations backK040139 Endobionics Microsyringe (Usyringe) Infusion CatheterEndobionics, Inc. · 2004
- 3 generations backK062752 Mercator Microsyringe II Infusion CatheterMercator Medsystems, Inc. · 2006
- 2 generations backK140637 Peregrine System Infusion CatheterAblative Solutions, Inc. · 2014
- 1 generation backK161402 Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc. · 2016
- This deviceK222185 Stratus Infusion CatheterIntervene, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913517 | Isolate Infusion Cathetr System | Lake Region Mfg., Inc. | 1991 | — |
| −4 | K040139 | Endobionics Microsyringe (Usyringe) Infusion Catheter | Endobionics, Inc. | 2004 | — |
| −3 | K062752 | Mercator Microsyringe II Infusion Catheter | Mercator Medsystems, Inc. | 2006 | — |
| −2 | K140637 | Peregrine System Infusion Catheter | Ablative Solutions, Inc. | 2014 | — |
| −1 | K161402 | Bullfrog Micro-Infusion Device | Mercator Medsystems, Inc. | 2016 | — |
| 0 (this device) | K222185 | Stratus Infusion Catheter | Intervene, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 2016 | 1 | 0 |
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 NPG? 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 |
|---|---|---|---|
| * | K161402 | Bullfrog Micro-Infusion DeviceSummary page 4…Continuous Flush Catheter Product Code/ Regulation: NPG / 21 CFR 870.1210 Classification: Class II Predicate Device: Bullfrog Micro-Infusion Device - K161402 Subject Device Description The Stratus™ Infusion Catheter is a peripheral infusion catheter designed to access an intraluminal,… | 2016 |
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 5 companies; a new generation was cleared every 6.7 years on median.
- None of the 8 ancestors has a recall.
- 2 other devices also cite its predicate K161402.
How does its category compare?
All NPG devicesNPG Catheter, Infusion, Syringe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · NPG
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NPG
Too few NPG 510(k)s in any year since 2007 to give a median.
Recalls per year · NPG
No recall names NPG since 2007.
Adverse event reports per year · NPG
No MAUDE report names NPG 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
In selective areas of peripheral veins between 7 and 16 mm in diameter, the Stratus Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents into the vein wall or perivascular area, or intraluminally.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222185 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222185: Stratus Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222185
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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