510(k) · Cleared
ClearedHand Drill, Model 11-9901-7
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Design, LLC · HBG Drills, Burrs, Trephines & Accessories (Manual)
Cleared on Nov 12, 2002 as substantially equivalent to K862160 (Camino Laboratories, Inc., 1986) after a 90-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it.
- Decided
- Nov 12, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- HBG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K862160 (1986). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K032125Cstat, Models 09-0014-01 and 09-0014-02Vascular Control Systems, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K862160 | Camino Hand Drill - Model 030 | Camino Laboratories, Inc. | 1986 | — |
| 0 (this device) | K022712 | Hand Drill, Model 11-9901-7 | Medical Design, LLC | 2002 | — |
| +1 | K032125 | Cstat, Models 09-0014-01 and 09-0014-02 | Vascular Control Systems, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 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? (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 |
|---|---|---|---|
| * | K862160 | Camino Hand Drill - Model 030Summary page 1…s I1 device (21 CFR 882.4300) 3. Predicate Device: Integra Neurosciences Camino Hand Drill - Model 030 (K862 160) 4. Performance Standards: No applicable performance standards… | 1986 |
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 |
|---|---|---|---|
| K032125 | Cstat, Models 09-0014-01 and 09-0014-02 | 2004 | 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?
- Its one ancestor has no recall.
- Of its descendants, K032125 (Vascular Control Systems, Inc., 2004) has gone furthest, with 0 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 | — |
What is it indicated for?
The Medical Designs Hand Drill is intended for use in
Neurosurgical procedures and for use with Medical Designs’
Subdural Evacuating Port System Kit (S.E.P.S),Catalog # 11 -
9901.
The Hand Drill is not intended for any use other than that
indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022712: Hand Drill, Model 11-9901-7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022712
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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