510(k) · Cleared
ClearedRaney Clips Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beijing Honghugaoxiang Science and Technology Development CO · HBO Clip, Scalp
Cleared on Jul 21, 2026 as substantially equivalent to K012219 (Aesculap, Inc., 2001) after a 235-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Jul 21, 2026
- Review
- 235 days
- Class
- Class II
- Product code
- HBO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890443 (1989). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890443 | Caspar Scalp Clip, Applier | Aesculap Instruments Corp. | 1989 | — |
| −1 | K012219 | Scalpfix Clip System | Aesculap, Inc. | 2001 | — |
| 0 (this device) | K253814 | Raney Clips Kit | Beijing Honghugaoxiang Science and Technology Development CO | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K012219 | Scalpfix Clip SystemSummary page 5…ssification: II Product Code: HBO Regulation Number: 21 CFR 882.4150 Review Panel: Neurology 5. Identification of Predicate Device 510(k) Number: K012219 Trade Name: ScalpFix Clip System 6. Indications for Use The Raney Clips Kit is indicated for use in temporary hemos… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 25.0 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K012219.
How does its category compare?
All HBO devicesHBO Clip, Scalp: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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?
The Raney Clips Kit 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/K253814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253814: Raney Clips Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253814
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026