510(k) · Cleared
Recalled · Class II · 2026PS Medical Ventriculostomy Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pudenz-Schulte Medical Research Corp. · HBG Drills, Burrs, Trephines & Accessories (Manual)
Cleared on Dec 30, 1991 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Dec 30, 1991
- Review
- 19 days
- Class
- Class II
- Product code
- HBG
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK915546 PS Medical Ventriculostomy KitPudenz-Schulte Medical Research Corp. · 1991
- Descendant · cites it directly · 2 of its ownK042359 Subdural Evacuating Port System Cranial Access Kit (Seps-CA)…Medical Designs, LLC · 2004 · Recalled
- Descendant · 2 generations on · 0 of its ownK252514 Evac-MriPhasor Health, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK241458 Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K042359Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)…Medical Designs, LLC · 2004 · cites it directly2descendants
- K252514Evac-MriPhasor Health, LLC · 2025 · 2 generations on0descendants
- K241458Borvo EVAC System (Ergo); Borvo EVAC System (Classic)Borvo Medical, Inc. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K915546 | PS Medical Ventriculostomy Kit | Pudenz-Schulte Medical Research Corp. | 1991 | — |
| +1 | K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)… | Medical Designs, LLC | 2004 | 1 |
| +2 | K252514 | Evac-Mri | Phasor Health, LLC | 2025 | — |
| +2 | K241458 | Borvo EVAC System (Ergo); Borvo EVAC System (Classic) | Borvo Medical, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HBG? 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 HBG device
- #1 K252696 Legacyscore 12.2 · 7 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042359 | Subdural Evacuating Port System Cranial Access Kit (Seps-CA), (Seps-Cal)… | 2004 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 17, 2026 | Class II | Z-2768-2026 | Process control | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular system, may exhibit endotoxin levels that exceed the acceptable limit for devices that come into contact with cerebrospinal fluid; endotoxin… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042359 (Medical Designs, LLC, 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HBG devicesHBG Drills, Burrs, Trephines & Accessories (Manual): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBG
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HBG
Too few HBG 510(k)s in any year since 2007 to give a median.
Recalls per year · HBG
9in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBG
2in 2025
MAUDE reports naming product code HBG, 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 | — | 1 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 14 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 14 | 5 |
| 2015 | 1 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 9 | 3 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K915546 · printed Nov 3, 2026
Cite this page
510(k) Report. “K915546: PS Medical Ventriculostomy Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K915546
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026