510(k) · Cleared
Recalled · Class II · 2024Centurion Circlamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tri-State Hospital Supply Corp. · HFX Clamp, Circumcision
Cleared on Mar 28, 1989 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- Mar 28, 1989
- Review
- 34 days
- Class
- Class II
- Product code
- HFX
- Recalls
- 7
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK890897 Centurion CirclampTri-State Hospital Supply Corp. · 1989
- Descendant · cites it directly · 1 of its ownK040052 Fine Surgical Circumcision ClampFine Surgical Instrument Corp. · 2004
- Descendant · 2 generations on · 0 of its ownK251687 Konig Bell Circumcision ClampMedline Industries, LP · 2026
- Descendant · cites it directly · 0 of its ownK043533 Surgical Design Circumcision ClampSurgical Design, Inc. · 2005 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K040052Fine Surgical Circumcision ClampFine Surgical Instrument Corp. · 2004 · cites it directly1descendant
- K251687Konig Bell Circumcision ClampMedline Industries, LP · 2026 · 2 generations on0descendants
- K043533Surgical Design Circumcision ClampSurgical Design, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K890897 | Centurion Circlamp | Tri-State Hospital Supply Corp. | 1989 | — |
| +1 | K040052 | Fine Surgical Circumcision Clamp | Fine Surgical Instrument Corp. | 2004 | — |
| +2 | K251687 | Konig Bell Circumcision Clamp | Medline Industries, LP | 2026 | — |
| +1 | K043533 | Surgical Design Circumcision Clamp | Surgical Design, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 3, 2024 | Class II | Z-0133-2025 | Device Design | Product has been identified as having holes in the packaging. |
| May 23, 2023 | Class II | Z-2649-2023 | Process control | The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size. |
| Mar 2, 2023 | Class II | Z-1407-2023 | Under Investigation by firm | The CirClamp subassembly found in the kit was the incorrect size. |
| Aug 28, 2019 | Class II | Z-0120-2020 | Process control | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. |
| Aug 28, 2019 | Class II | Z-0121-2020 | Process control | A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel. |
| Apr 12, 2005 | Not classified | Z-0837-05 | Other | Not labeled as reprocessed, when this lot has been reprocessed. |
| Apr 12, 2005 | Not classified | Z-0836-05 | Other | Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040052 (Fine Surgical Instrument Corp., 2004) 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 | — |
https://510kreport.com/device/K890897 · printed Nov 3, 2026
Cite this page
510(k) Report. “K890897: Centurion Circlamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K890897
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026