De Novo · Granted
GrantedSurfacer Inside-Out Access Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluegrass Vascular Technologies, Inc. · QJH Reverse Central Venous Recanalization System
Granted on Feb 10, 2020 as a new device type through De Novo after a 179-day review. 1 later device descends from it.
- Decided
- Feb 10, 2020
- Review
- 179 days
- Class
- Class II
- Product code
- QJH
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN190038 Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK252527 Surfacer Inside-Out Access Catheter SystemMerit Medical System, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K252527Surfacer Inside-Out Access Catheter SystemMerit Medical System, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN190038 | Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. | 2020 | — |
| +1 | K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA De Novo 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 QJH? 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 QJH device
- #1 K252527 Surfacer Inside-Out Access Catheter Systemscore 10.0 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252527 | Surfacer Inside-Out Access Catheter System | 2025 | 0 |
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?
- Of its descendants, K252527 (Merit Medical System, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QJH devicesQJH Reverse Central Venous Recanalization System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · QJH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QJH
Too few QJH 510(k)s in any year since 2007 to give a median.
Recalls per year · QJH
No recall names QJH since 2007.
Adverse event reports per year · QJH
3in 2025
MAUDE reports naming product code QJH, 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 | 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 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Surfacer Inside-Out Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN190038 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN190038: Surfacer Inside-Out Access Catheter System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN190038
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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