# K890897: Centurion Circlamp

- Pathway: 510(k) (Traditional)
- Applicant: Tri-State Hospital Supply Corp.
- Decided: Mar 28, 1989 after 34 days
- Product code: HFX (Clamp, Circumcision)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K040052: Fine Surgical Circumcision Clamp (2004), 1 descendant of its own
- K251687: Konig Bell Circumcision Clamp (2026), 0 descendants of its own
- K043533: Surgical Design Circumcision Clamp (2005), 0 descendants of its own

## Recalls of this device
- Sep 3, 2024 · Class II · Z-0133-2025: Product has been identified as having holes in the packaging.
- May 23, 2023 · Class II · Z-2649-2023: 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: The CirClamp subassembly found in the kit was the incorrect size.
- Aug 28, 2019 · Class II · Z-0120-2020: 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: 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: Not labeled as reprocessed, when this lot has been reprocessed.
- Apr 12, 2005 · Not classified · Z-0836-05: Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.

Source page: https://510kreport.com/device/K890897
Methodology: https://510kreport.com/methodology