510(k) · Cleared
ClearedKonig Mogen Clamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · HFX Clamp, Circumcision
Cleared on Nov 18, 2022 as substantially equivalent to K100916 (Medicon EG, 2010) after a 431-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Nov 18, 2022
- Review
- 431 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935491 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK935491 Centurion Mogen Clamp/Circumcision (Ster/Non Ster)Tri-State Hospital Supply Corp. · 1994
- 2 generations backK033403 T.S. Medical Circumcision ClampT.S. Medical · 2004
- 1 generation backK100916 Medicon Mogen ClampMedicon EG · 2010
- This deviceK212911 Konig Mogen ClampMedline Industries, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935491 | Centurion Mogen Clamp/Circumcision (Ster/Non Ster) | Tri-State Hospital Supply Corp. | 1994 | — |
| −2 | K033403 | T.S. Medical Circumcision Clamp | T.S. Medical | 2004 | — |
| −1 | K100916 | Medicon Mogen Clamp | Medicon EG | 2010 | — |
| 0 (this device) | K212911 | Konig Mogen Clamp | Medline Industries, Inc. | 2022 | — |
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
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 |
|---|---|---|---|
| * | K100916 | Medicon Mogen ClampSummary page 4…Product Code: HFX Classification Panel: Obstetrics/Gynecology Regulatory Class: Class II Regulation #: 21 CFR 884.4530 Predicate Device Medicon Mogen Circumcision Clamp K100916 Device Description The Konig Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis duri… | 2010 |
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 28 years and passes through 4 companies; a new generation was cleared every 9.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All HFX devicesHFX Clamp, Circumcision: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Mogen Clamp is an instrument used in a medical procedure to compress the foreskin of the penis during the circumcision of a male infant or child only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212911 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212911: Konig Mogen Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212911
Report an extraction error
Are you the manufacturer?
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