510(k) · Cleared
ClearedCircumplast Circumcision Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novadien Healthcare · HFX Clamp, Circumcision
Cleared on Sep 18, 2015 as substantially equivalent to K032091 (Emergogroup, Inc., 2004) after a 148-day review. Its family tree reaches back 1 generation to 2004. 1 later device descends from it.
- Decided
- Sep 18, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032091 (2004). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K221356Wee BellWee Medical · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032091 | Smart Klamp Various by Size | Emergogroup, Inc. | 2004 | — |
| 0 (this device) | K151095 | Circumplast Circumcision Device | Novadien Healthcare | 2015 | — |
| +1 | K221356 | Wee Bell | Wee Medical | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 HFX? 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 HFX device
- #1 K251687 Konig Bell Circumcision Clampscore 11.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K032091 | Smart Klamp Various by SizeSummary page 4…Device Class: Class II Classification Panel: Obstetrics/Gynecology Panel 5. Legally Marketed Predicate Device(s) SmartKlamp (Circumvent BV, K032091) 6. Device Description The Circumplast is a device composed of two components, a transparent plastic conic tube, and a li… | 2004 |
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 |
|---|---|---|---|
| K221356 | Wee Bell | 2023 | 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?
How does its category compare?
All HFX devicesHFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HFX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HFX
Too few HFX 510(k)s in any year since 2007 to give a median.
Recalls per year · HFX
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HFX
122in 2025
MAUDE reports naming product code HFX, 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 | 2 | — | 0 | 17 |
| 2008 | 0 | — | 0 | 6 |
| 2009 | 0 | — | 0 | 20 |
| 2010 | 1 | — | 0 | 21 |
| 2011 | 0 | — | 3 | 12 |
| 2012 | 2 | — | 0 | 14 |
| 2013 | 1 | — | 0 | 16 |
| 2014 | 0 | — | 2 | 20 |
| 2015 | 2 | — | 0 | 21 |
| 2016 | 0 | — | 1 | 147 |
| 2017 | 0 | — | 0 | 25 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 2 | 11 |
| 2020 | 0 | — | 0 | 22 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 0 | — | 1 | 121 |
| 2025 | 0 | — | 0 | 122 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Circumplast single use circumcision device is intended to be used to perform circumcisions on infant males. This device consists of two components: Circumplast Circumcision Device and Ligature. The Ligature was tested for use with Circumplast Circumcision Device only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151095: Circumplast Circumcision Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151095
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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