510(k) · Decided
DecidedSurfacer Inside-Out Access Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical System, Inc. · QJH Reverse Central Venous Recanalization System
Cleared on Sep 10, 2025 as substantially equivalent to DEN190038 (Bluegrass Vascular Technologies, Inc., 2020) after a 30-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Sep 10, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- QJH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN190038 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN190038 Surfacer Inside-Out Access Catheter SystemBluegrass Vascular Technologies, Inc. · 2020
- This deviceK252527 Surfacer Inside-Out Access Catheter SystemMerit Medical System, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN190038 | Surfacer Inside-Out Access Catheter System | Bluegrass Vascular Technologies, Inc. | 2020 | — |
| 0 (this device) | K252527 | Surfacer Inside-Out Access Catheter System | Merit Medical System, Inc. | 2025 | — |
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 QJH? 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 |
|---|---|---|---|
| * | DEN190038 | Surfacer Inside-Out Access Catheter SystemSummary page 5…strate that the subject device Surfacer Inside-Out Access Catheter System is substantially equivalent to the predicate device Surfacer Inside-Out Access Catheter System, DEN190038. The subject of the Special 510(k) is to notify FDA of Merit’s intent to distribute the Surfacer Inside-Out Access Catheter Sys… | 2020 |
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 QJH devicesQJH Reverse Central Venous Recanalization System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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/K252527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252527: Surfacer Inside-Out Access Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252527
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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