510(k) · Cleared
ClearedBOSS 8F Balloon Guide Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Marblehead Medical, LLC · QJP Catheter, Percutaneous, Neurovasculature
Cleared on Jan 28, 2021 as substantially equivalent to K200910 (Marblehead Medical, 2020) after a 28-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jan 28, 2021
- Review
- 28 days
- Class
- Class II
- Product code
- QJP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K010954 (2001). 14 ancestors in all, the oldest K010853 (2001). No later device cites it as a predicate yet.
- Root · 8 generations backK010954 Concentric Balloon Guide Catheter, Model 90031Concentric Medical, Inc. · 2001 · Recalled
- 7 generations backK021899 Concentric Balloon Guide Catheter, Model 90072Concentric Medical, Inc. · 2002 · Recalled
- 6 generations backK102657 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2010
- 5 generations backK112404 Concentric Balloon Guide CatheterConcentric Medical, Inc. · 2012 · Recalled
- 4 generations backK122581 Modified Balloon Guide Catheter Model 90253, 90254Concentric Medical, Inc. · 2012 · Recalled
- 3 generations backK131492 Modified Flowgate Balloon Guide CatheterConcentric Medical, Inc. · 2013
- 2 generations backK153729 8F FlowGate2 Balloon Guide CatheterConcentric Medical · 2016 · Recalled
- 1 generation backK200910 BOSS Balloon Guide CatheterMarblehead Medical · 2020
- This deviceK203840 BOSS 8F Balloon Guide CatheterMarblehead Medical, LLC · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K010954 | Concentric Balloon Guide Catheter, Model 90031 | Concentric Medical, Inc. | 2001 | 1 |
| −7 | K021899 | Concentric Balloon Guide Catheter, Model 90072 | Concentric Medical, Inc. | 2002 | 1 |
| −6 | K102657 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2010 | — |
| −5 | K112404 | Concentric Balloon Guide Catheter | Concentric Medical, Inc. | 2012 | 1 |
| −4 | K122581 | Modified Balloon Guide Catheter Model 90253, 90254 | Concentric Medical, Inc. | 2012 | 1 |
| −3 | K131492 | Modified Flowgate Balloon Guide Catheter | Concentric Medical, Inc. | 2013 | — |
| −2 | K153729 | 8F FlowGate2 Balloon Guide Catheter | Concentric Medical | 2016 | 2 |
| −1 | K200910 | BOSS Balloon Guide Catheter | Marblehead Medical | 2020 | — |
| 0 (this device) | K203840 | BOSS 8F Balloon Guide Catheter | Marblehead Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 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 QJP? 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 QJP device
- #1 K212838 Benchmark Intracranial Access Systemscore 16.9 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K200910 | BOSS Balloon Guide CatheterSummary page 4…Class II Regulation Number: 21 CFR 870.1250 PREDICATE [807.92(a)(3)] Primary Predicate Device: BOSS Balloon Guide Catheter, K200910 DEVICE DESCRIPTION [807.92(a)(4)] The BOSS 8F Balloon Guide Catheter system is a sterile, single-use intravascular catheter. The… | 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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 9 of the 14 ancestors have a recall of any class.
How does its category compare?
All QJP devicesQJP Catheter, Percutaneous, Neurovasculature: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QJP
22so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QJP
116in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QJP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QJP
688in 2025
MAUDE reports naming product code QJP, 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 | 9 | 72 | 0 | 16 |
| 2021 | 12 | 139 | 0 | 29 |
| 2022 | 14 | 206 | 0 | 30 |
| 2023 | 14 | 184 | 0 | 75 |
| 2024 | 18 | 188 | 1 | 130 |
| 2025 | 14 | 116 | 0 | 688 |
| 2026 | 22 | 141 | 0 | — |
What is it indicated for?
The BOSS™ 8F Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these procedures. The balloon guide catheter is also indicated for use as a conduit for retrieval devices.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203840 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203840: BOSS 8F Balloon Guide Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203840
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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