510(k) · Cleared
ClearedScalpfix Clip System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · HBO Clip, Scalp
Cleared on Jul 31, 2001 as substantially equivalent to K890443 (Aesculap Instruments Corp., 1989) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Jul 31, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- HBO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K890443 (1989). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK890443 Caspar Scalp Clip, ApplierAesculap Instruments Corp. · 1989
- This deviceK012219 Scalpfix Clip SystemAesculap, Inc. · 2001
- Descendant · cites it directly · 2 of its ownK132651 Itclamp 50Innovative Trauma Care, Inc. · 2013
- Descendant · 2 generations on · 1 of its ownK140805 Itclamp 50Innovative Trauma Care, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK253814 Raney Clips KitBeijing Honghugaoxiang Science and Technology Development CO · 2026
- Descendant · 3 generations on · 0 of its ownK150813 iTClamp50Innovative Trauma Care, Inc. · 2015
Most influential descendants
Showing 4 of 4 · See all- K132651Itclamp 50Innovative Trauma Care, Inc. · 2013 · cites it directly2descendants
- K140805Itclamp 50Innovative Trauma Care, Inc. · 2014 · 2 generations on1descendant
- K253814Raney Clips KitBeijing Honghugaoxiang Science and Technology Development CO · 2026 · cites it directly0descendants
- K150813iTClamp50Innovative Trauma Care, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890443 | Caspar Scalp Clip, Applier | Aesculap Instruments Corp. | 1989 | — |
| 0 (this device) | K012219 | Scalpfix Clip System | Aesculap, Inc. | 2001 | — |
| +1 | K132651 | Itclamp 50 | Innovative Trauma Care, Inc. | 2013 | — |
| +2 | K140805 | Itclamp 50 | Innovative Trauma Care, Inc. | 2014 | — |
| +1 | K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | 2026 | — |
| +3 | K150813 | iTClamp50 | Innovative Trauma Care, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 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 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? (3)
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 |
|---|---|---|---|
| * | K890443 | Caspar Scalp Clip, ApplierSummary page 1…The new ScalpFix Clip System described in this premarket notification is substantially equivalent to those in Aesculap’s current Caspar Scalp Clip System (subjected to K890443) and the following other predicate devices: « Acra-Cut (500-102 & 500-105) (K944311) « Codman & Shurtleff Disposable Scalp Clip… | 1989 |
| * | K944311 | Acra-CutSummary page 1…ly equivalent to those in Aesculap’s current Caspar Scalp Clip System (subjected to K890443) and the following other predicate devices: « Acra-Cut (500-102 & 500-105) (K944311) « Codman & Shurtleff Disposable Scalp Clip / Applier (KS05433) 0005 &’“‘wc“'b(' $ : g @ DEPARTMENT OF HEALTH &… | 1994 |
| * | K905433 | Codman Disposable Scalp Clip Applier Our OCR of the scanned summary read K505433, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Codman & Shurtleff Disposable Scalp Clip / Applier”. | 1991 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K132651 (Innovative Trauma Care, Inc., 2013) has gone furthest, with 2 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 | — |
What is it indicated for?
Aesculap's Scalpfix is indicated for use in temporary hemostasis of the scalp edge.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012219: Scalpfix Clip System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012219
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026