510(k) · Cleared
ClearedCodman Disposable Scalp Clip Applier
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Codman & Shurtleff, Inc. · HBO Clip, Scalp
Cleared on Feb 21, 1991 after a 79-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 21, 1991
- Review
- 79 days
- Class
- Class II
- Product code
- HBO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK905433 Codman Disposable Scalp Clip ApplierCodman & Shurtleff, Inc. · 1991
- Descendant · cites it directly · 4 of its ownK012219 Scalpfix Clip SystemAesculap, Inc. · 2001
- Descendant · 2 generations on · 2 of its ownK132651 Itclamp 50Innovative Trauma Care, Inc. · 2013
- Descendant · 3 generations on · 1 of its ownK140805 Itclamp 50Innovative Trauma Care, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK253814 Raney Clips KitBeijing Honghugaoxiang Science and Technology Development CO · 2026
- Descendant · 4 generations on · 0 of its ownK150813 iTClamp50Innovative Trauma Care, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K012219Scalpfix Clip SystemAesculap, Inc. · 2001 · cites it directly4descendants
- K132651Itclamp 50Innovative Trauma Care, Inc. · 2013 · 2 generations on2descendants
- K140805Itclamp 50Innovative Trauma Care, Inc. · 2014 · 3 generations on1descendant
- K253814Raney Clips KitBeijing Honghugaoxiang Science and Technology Development CO · 2026 · 2 generations on0descendants
- K150813iTClamp50Innovative Trauma Care, Inc. · 2015 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905433 | Codman Disposable Scalp Clip Applier | Codman & Shurtleff, Inc. | 1991 | — |
| +1 | K012219 | Scalpfix Clip System | Aesculap, Inc. | 2001 | — |
| +2 | K132651 | Itclamp 50 | Innovative Trauma Care, Inc. | 2013 | — |
| +3 | K140805 | Itclamp 50 | Innovative Trauma Care, Inc. | 2014 | — |
| +2 | K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | 2026 | — |
| +4 | K150813 | iTClamp50 | Innovative Trauma Care, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 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 HBO? 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 HBO device
- #1 K253814 Raney Clips Kitscore 12.0 · 2 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? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012219 | Scalpfix Clip System | 2001 | 4 |
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?
- Of its descendants, K012219 (Aesculap, Inc., 2001) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HBO devicesHBO Clip, Scalp: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HBO
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · HBO
Too few HBO 510(k)s in any year since 2007 to give a median.
Recalls per year · HBO
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HBO
4in 2025
MAUDE reports naming product code HBO, 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 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 1 | 12 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 12 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K905433 · printed Nov 3, 2026
Cite this page
510(k) Report. “K905433: Codman Disposable Scalp Clip Applier.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K905433
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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