510(k) · Cleared
ClearedHemedex Cranial Bolt Models, 3601, 3602
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 21, 2003 as substantially equivalent to K992591 (Codman & Shurtleff, Inc., 1999) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1998. 1 later device descends from it.
- Decided
- Oct 21, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- GWM
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K974088 (1998). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK974088 Codman Intracranial BoltJohnson & Johnson Professionals, Inc. · 1998 · Recalled
- This deviceK032337 Hemedex Cranial Bolt Models, 3601, 3602Hemedex Incorporated · 2003
- Descendant · cites it directly · 0 of its ownK141869 Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated · 2014
Most influential descendants
Showing 1 of 1 · See all- K141869Qflow 500 Titanium Bolt, Quad Lumen Bolt KitHemedex Incorporated · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974088 | Codman Intracranial Bolt | Johnson & Johnson Professionals, Inc. | 1998 | 1 |
| 0 (this device) | K032337 | Hemedex Cranial Bolt Models, 3601, 3602 | Hemedex Incorporated | 2003 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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? (4)
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 |
|---|---|---|---|
| * | K992591 | Codman Single and Double Lumen Skull Bolt KitsSummary page 1…ranial Bolt Hemedex Double Lumen Cranial Bolt 3. Identificationof Predicate or Legally Marketed Devices: Codman Skull Bolt (K992591) Codman Intracranial Bolt (K974088) Integra Licox Brain Monitoring System (K002765) P… | 1999 |
| * | K974088 | Codman Intracranial BoltSummary page 1…nial Bolt 3. Identificationof Predicate or Legally Marketed Devices: Codman Skull Bolt (K992591) Codman Intracranial Bolt (K974088) Integra Licox Brain Monitoring System (K002765) Part Number IM1, IM2, IM3 Codman Dis… | 1998 |
| * | K002765 | Licox CMP Monitor-AC3.1, Licox Imc Oxygen Catheters-CC1,CC1.SB Luicox Imc Introducer…Summary page 1…: Codman Skull Bolt (K992591) Codman Intracranial Bolt (K974088) Integra Licox Brain Monitoring System (K002765) Part Number IM1, IM2, IM3 Codman Disposable ICP Kit with Stainless Steel Screw Catalog No. 8@1194 4. D… | 2000 |
| * | — | Codman Disposable ICP Kit with Stainless Steel Screw Named without a submission number |
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 |
|---|---|---|---|
| K141869 | Qflow 500 Titanium Bolt, Quad Lumen Bolt Kit | 2014 | 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?
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K141869 (Hemedex Incorporated, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GWM devicesGWM Device, Monitoring, Intracranial Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Single and Double Lumen Bolts are designed to achieve cranial access and to introduce and secure a sensor in place for intracranial monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032337: Hemedex Cranial Bolt Models, 3601, 3602.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032337
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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