# K014060: Microaire 1000E System

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments, Inc.
- Decided: Mar 5, 2002 after 85 days
- Product code: HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered))
- Device class: 2
- Regulation: 21 CFR 882.4310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K931783 (1993). 12 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991696: Stryker Hermes-Ready Total Performance System, Stryker Instruments (1999) Summary page 1.

## Most influential descendants
- K161704: Phasor Drill (2016), 4 descendants of its own
- K230619: Hubly Electric Drill (H100) (2023), 1 descendant of its own
- K252696: Legacy (2025), 0 descendants of its own
- K250815: Hubly Drill (H100) (2025), 0 descendants of its own
- K252060: GREEN (2025), 0 descendants of its own

## Indications for use
The MicroAire® 1000E System is indicated for use in cutting, sawing, drilling, reaming, wire driving, pinning, screw driving, decorticating, shaping and manipulation of bone and other bone related tissue in a variety surgical procedures. The applications include ENT, maxilliofacial, neurological, oral, orthopedic, plastic, podiatric and spinal surgery.

Source page: https://510kreport.com/device/K014060
Methodology: https://510kreport.com/methodology