510(k) · Cleared
ClearedQflow 500 Titanium Bolt, Quad Lumen Bolt Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemedex Incorporated · GWM Device, Monitoring, Intracranial Pressure
Cleared on Oct 10, 2014 as substantially equivalent to K032337 (Hemedex Incorporated, 2003) and 1 other predicate after a 91-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Oct 10, 2014
- Review
- 91 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K974088 (1998). 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 | K974088 | Codman Intracranial Bolt | Johnson & Johnson Professionals, Inc. | 1998 | 1 |
| −1 | K032337 | Hemedex Cranial Bolt Models, 3601, 3602 | Hemedex Incorporated | 2003 | — |
| 0 (this device) | K141869 | Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit | Hemedex Incorporated | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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 GWM? 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 GWM device
- #1 K252241 Pressio 3 Multi-parameter Neuromonitoring Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032337 | Hemedex Cranial Bolt Models, 3601, 3602Summary page 4…ntial Equivalence The QFlow 500TM Titanium Bolt Kit is substantially equivalent in intended use, function and design to the Hemedex Single and Dual Lumen Cranial Bolts (K032337), as well as the Integra Licox Brain Monitoring System, PN IM1, IM2, IM3 (K002765). Hemedex, Inc. Cranial Bolt Pr… | 2003 |
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 4…n intended use, function and design to the Hemedex Single and Dual Lumen Cranial Bolts (K032337), as well as the Integra Licox Brain Monitoring System, PN IM1, IM2, IM3 (K002765). Hemedex, Inc. Cranial Bolt Premarket Notification Purpose This submission covers design changes to predicate… | 2000 |
| † | K992591 | Codman Single and Double Lumen Skull Bolt Kits | 1999 |
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 16 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 4 ancestors have a recall of any class.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · GWM
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GWM
30in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GWM
3in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · GWM
441in 2025
MAUDE reports naming product code GWM, 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 | — | 0 | 126 |
| 2008 | 2 | — | 1 | 105 |
| 2009 | 1 | — | 0 | 117 |
| 2010 | 2 | — | 9 | 104 |
| 2011 | 3 | 123 | 6 | 184 |
| 2012 | 4 | 100 | 1 | 151 |
| 2013 | 2 | — | 12 | 120 |
| 2014 | 2 | — | 2 | 360 |
| 2015 | 0 | — | 0 | 486 |
| 2016 | 3 | 192 | 0 | 419 |
| 2017 | 3 | 37 | 0 | 445 |
| 2018 | 1 | — | 0 | 302 |
| 2019 | 2 | — | 1 | 260 |
| 2020 | 3 | 30 | 0 | 268 |
| 2021 | 2 | — | 0 | 211 |
| 2022 | 0 | — | 0 | 424 |
| 2023 | 0 | — | 1 (1) | 744 |
| 2024 | 2 | — | 4 (2) | 641 |
| 2025 | 1 | — | 3 | 441 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Hemedex Cranial Bolt is designed to achieve cranial access and to introduce and secure one to four sensors in place for intracranial monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141869: Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141869
Report an extraction error
Are you the manufacturer?
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