510(k) · Cleared
ClearedKonig Bell Circumcision Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, LP · HFX Clamp, Circumcision
Cleared on Feb 25, 2026 as substantially equivalent to K040052 (Fine Surgical Instrument Corp., 2004) after a 268-day review. Its family tree reaches back 2 generations to 1989.
- Decided
- Feb 25, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890897 (1989). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K221356 Wee Bellscore 5.1 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K040052 | Fine Surgical Circumcision ClampSummary page 5…ct Code: HFX Classification Panel: Obstetrics/Gynecology Regulatory Class: Class II Regulation Number: 21 CFR 884.4530 Predicate Device Fine Surgical Circumcision Clamp K040052 Device Description The Konig Bell Circumcision Clamp is intended to be used in a medical procedure to compress the foreskin of t… | 2004 |
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 21.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All HFX devicesHFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 Konig Bell Circumcision clamps are reusable instruments used in a procedure to compress the foreskin of the penis during the circumcision of male infant or child. Use of the Konig Bell Circumcision clamps in adults is to assist in Human Immunodeficiency Virus (HIV) prevention.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251687 · printed Nov 5, 2026
Cite this page
510(k) Report. “K251687: Konig Bell Circumcision Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K251687
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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