# K900388: Modified Sterilization of Drills, Burrs, Trephines

- Pathway: 510(k) (Traditional)
- Applicant: Midas Rex Pneumatic Tools, Inc.
- Decided: May 7, 1990 after 98 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K960473: Aesculap Power System Handpiece (1996), 0 descendants of its own

## Recalls of this device
- Sep 1, 2005 · Not classified · Z-1574-05: Potential compromise of sterile packaging for disposable dissecting tools.

Source page: https://510kreport.com/device/K900388
Methodology: https://510kreport.com/methodology