510(k) · Cleared
ClearedMicro Prime
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovx Medical, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cleared on Aug 16, 2004 as substantially equivalent to K024069 (Medtronic Vascular, 2003) and 2 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1981.
- Decided
- Aug 16, 2004
- Review
- 60 days
- Class
- Class II
- Product code
- DWF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K803277 (1981). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803277 | Tygon Tubing | Electromedics, Inc. | 1981 | 1 |
| −1 | K964205 | Better-Tubing | Circulatory Technology, Inc. | 1998 | — |
| 0 (this device) | K041650 | Micro Prime | Innovx Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 2003 | 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 DWF? 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 DWF device
- #1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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 | Decided |
|---|---|---|---|
| * | K024069 | One Piece Pediatric Arterial Cannula, Model: 77006, 77106Summary page 1…ed safely for more than two decades (K843444.) Predicate product, such as the Medtronic One Piece Pediatric Cannula are focused to the pediatric patient's special needs (K024069) Standard tubing sets (arterial and cardioplegia) from PVC are well recognized in the predicate device literature (K803277 predic… | 2003 |
| * | K803277 | Tygon TubingSummary page 1…used to the pediatric patient's special needs (K024069) Standard tubing sets (arterial and cardioplegia) from PVC are well recognized in the predicate device literature (K803277 predicate use of Tygon PVC tubing, and K964205, Better-Tubing TM) DESCRIPTION of the DEVICE: Micro Prime Del… | 1981 |
| * | K964205 | Better-TubingSummary page 1…K024069) Standard tubing sets (arterial and cardioplegia) from PVC are well recognized in the predicate device literature (K803277 predicate use of Tygon PVC tubing, and K964205, Better-Tubing TM) DESCRIPTION of the DEVICE: Micro Prime Delivery Lines minimize the blood prime volume in… | 1998 |
| † | K843444 | Argyle Silicone Left Ventricular and | 1984 |
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 23 years and passes through 3 companies; a new generation was cleared every 17.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K024069.
How does its category compare?
All DWF devicesDWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DWF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWF
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWF
4in 2024
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DWF
1,020in 2025
MAUDE reports naming product code DWF, 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 | 2 | — | 25 | 121 |
| 2008 | 6 | 95 | 25 | 126 |
| 2009 | 8 | 148 | 21 | 99 |
| 2010 | 3 | 62 | 26 | 197 |
| 2011 | 5 | 85 | 13 | 212 |
| 2012 | 10 | 110 | 37 | 233 |
| 2013 | 9 | 110 | 14 (1) | 238 |
| 2014 | 14 | 110 | 6 | 325 |
| 2015 | 9 | 46 | 3 (1) | 218 |
| 2016 | 3 | 32 | 3 | 144 |
| 2017 | 5 | 127 | 2 (1) | 101 |
| 2018 | 5 | 30 | 10 | 118 |
| 2019 | 3 | 120 | 2 | 179 |
| 2020 | 3 | 30 | 0 | 142 |
| 2021 | 5 | 358 | 3 | 162 |
| 2022 | 2 | — | 0 | 276 |
| 2023 | 2 | — | 0 | 470 |
| 2024 | 3 | 29 | 4 | 401 |
| 2025 | 4 | 89 | 0 | 1,020 |
| 2026 | 8 | 81 | 20 | — |
What is it indicated for?
Micro Prime Delivery Lines are indicated for use to convey arterial blood and cardioplegia with minimal prime volume in the extracorporeal circuit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041650 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041650: Micro Prime.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041650
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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