510(k) · Cleared
ClearedSmart Klamp Various by Size
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emergogroup, Inc. · HFX Clamp, Circumcision
Cleared on Mar 8, 2004 after a 245-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 8, 2004
- Review
- 245 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK032091 Smart Klamp Various by SizeEmergogroup, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK151095 Circumplast Circumcision DeviceNovadien Healthcare · 2015
- Descendant · cites it directly · 1 of its ownK121789 ShangringWuhu Snna Medical Treatment Appliance Technology C · 2012
- Descendant · 2 generations on · 0 of its ownK221356 Wee BellWee Medical · 2023
- Descendant · cites it directly · 0 of its ownK142163 Male Circumcision Kits:RapideclampMedicfit Technology Sdn Bhd · 2015
- Descendant · cites it directly · 0 of its ownK103695 Prepex SystemCirc Medtech · 2012
Most influential descendants
Showing 5 of 5 · See all- K151095Circumplast Circumcision DeviceNovadien Healthcare · 2015 · cites it directly1descendant
- K121789ShangringWuhu Snna Medical Treatment Appliance Technology C · 2012 · cites it directly1descendant
- K221356Wee BellWee Medical · 2023 · 2 generations on0descendants
- K142163Male Circumcision Kits:RapideclampMedicfit Technology Sdn Bhd · 2015 · cites it directly0descendants
- K103695Prepex SystemCirc Medtech · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K032091 | Smart Klamp Various by Size | Emergogroup, Inc. | 2004 | — |
| +1 | K151095 | Circumplast Circumcision Device | Novadien Healthcare | 2015 | — |
| +1 | K121789 | Shangring | Wuhu Snna Medical Treatment Appliance Technology C | 2012 | — |
| +2 | K221356 | Wee Bell | Wee Medical | 2023 | — |
| +1 | K142163 | Male Circumcision Kits:Rapideclamp | Medicfit Technology Sdn Bhd | 2015 | — |
| +1 | K103695 | Prepex System | Circ Medtech | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 2 | 0 |
| 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? (4)
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 |
|---|---|---|---|
| * | — | Kilejian Circumcisor Named without a submission number | |
| * | — | Gomco Circumcision Clamp Named without a submission number | |
| * | — | Mogan Circumcision Clamp Named without a submission number | |
| * | — | Hollister Plastibell Named without a submission number |
What descends from it? (5)
4 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?
- Of its descendants, K151095 (Novadien Healthcare, 2015) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HFX devicesHFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Circumcision of newborns and older males, defined as circumferential excision of the foreskin or prepuce at or near the level of coronal sulcus, with minimal amount of preputial skin remaining.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032091 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032091: Smart Klamp Various by Size.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032091
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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