510(k) · Cleared
ClearedMedline Circumcision Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline · HFX Clamp, Circumcision
Cleared on Mar 6, 1997 after a 41-day review. The FDA summary names no predicate by number.
- Decided
- Mar 6, 1997
- Review
- 41 days
- Class
- Class II
- Product code
- HFX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
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?
Medline Circumcision Trays are intended for use by licensed physicians. The intended use of the medical products assembled in these kits will not be changed from the manufacturer’s original intended use.
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/K970282 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970282: Medline Circumcision Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970282
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026