# K183581: Codman Disposable Perforators

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Jan 20, 2019 after 30 days
- Product code: HBF (Drills, Burrs, Trephines & Accessories (Compound, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4305
- Recalls of this device: 3 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K791101 (1979). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791101: Disposable Perforators, Jacobs, Hudson, Codman & Shurtleff, Inc. (1979) Summary page 4.
- K071931: Codman Disposable Perforator, Model (S) 26-1222, 26-1223, Codman & Shurtleff, Inc. (2007) Summary page 4.

## Recalls of this device
- Sep 26, 2025 · Class I · Z-0373-2026: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- Sep 26, 2025 · Class I · Z-0374-2026: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
- Apr 11, 2025 · Class I · Z-1716-2025: Inadequate weld that can potentially cause the product to disassemble.

## Indications for use
The Codman Disposable Perforator is for use in perforating the cranium. When properly used, it is designed to automatically disengage once perforation is accomplished and when pressure is removed from the drill point.

Source page: https://510kreport.com/device/K183581
Methodology: https://510kreport.com/methodology