510(k) · Cleared
Recalled · Class II · 2025Merit HI-Flex (TM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · FPK Tubing, Fluid Delivery
Cleared on Jan 30, 1989 after a 152-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it. It has been recalled 5 times.
- Decided
- Jan 30, 1989
- Review
- 152 days
- Class
- Class II
- Product code
- FPK
- Recalls
- 5
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK883718 Merit HI-Flex (TM)Merit Medical Systems, Inc. · 1989
- Descendant · cites it directly · 13 of its ownK051917 Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · Recalled
- Descendant · 2 generations on · 12 of its ownK071727 QXT Extraction CatheterVascular Solutions, Inc. · 2007
- Descendant · 3 generations on · 11 of its ownK072810 Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007
- Descendant · 4 generations on · 10 of its ownK083784 Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction…Vascular Solutions, Inc. · 2009
- Descendant · 5 generations on · 4 of its ownK103405 Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter…Vascular Solutions, Inc. · 2010 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L. · 2005 · cites it directly13descendants
- K071727QXT Extraction CatheterVascular Solutions, Inc. · 2007 · 2 generations on12descendants
- K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc. · 2007 · 3 generations on11descendants
- K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc. · 2009 · 4 generations on10descendants
- K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc. · 2010 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K883718 | Merit HI-Flex (TM) | Merit Medical Systems, Inc. | 1989 | — |
| +1 | K051917 | Diver C.E. Catheter | Invatec Innovative Technologies, S.R.L. | 2005 | 1 |
| +2 | K071727 | QXT Extraction Catheter | Vascular Solutions, Inc. | 2007 | — |
| +3 | K072810 | Pronto Low Profile (LP) Extraction Catheter, Model 5010 | Vascular Solutions, Inc. | 2007 | — |
| +4 | K083784 | Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model… | Vascular Solutions, Inc. | 2009 | — |
| +5 | K103405 | Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto… | Vascular Solutions, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPK? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051917 | Diver C.E. Catheter | 2005 | 13 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2025 | Class II | Z-2293-2025 | Process control | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient. |
| Mar 13, 2014 | Class II | Z-1319-2014 | Release of Material/Component prior to receiving test results | The products are labeled as sterile but were not sterilized. |
| Feb 13, 2003 | Not classified | Z-0620-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
| Feb 13, 2003 | Not classified | Z-0621-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
| Feb 13, 2003 | Not classified | Z-0622-03 | Other | A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051917 (Invatec Innovative Technologies, S.R.L., 2005) has gone furthest, with 13 descendants of its own.
How does its category compare?
All FPK devicesFPK Tubing, Fluid Delivery: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · FPK
Too few FPK 510(k)s in any year since 2007 to give a median.
Recalls per year · FPK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FPK
30in 2025
MAUDE reports naming product code FPK, 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 | 1 | — | 0 | 29 |
| 2008 | 0 | — | 9 | 78 |
| 2009 | 0 | — | 0 | 92 |
| 2010 | 0 | — | 0 | 67 |
| 2011 | 0 | — | 0 | 112 |
| 2012 | 0 | — | 14 | 107 |
| 2013 | 1 | — | 1 | 29 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 1 | 15 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 10 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 15 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 30 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K883718 · printed Nov 6, 2026
Cite this page
510(k) Report. “K883718: Merit HI-Flex (TM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K883718
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026