# K030917: Gem; Hawk; Eagle; Models 004110, 0044120, 004130

- Pathway: 510(k) (Special)
- Applicant: Collins Medical, Inc.
- Decided: May 14, 2003 after 51 days
- Product code: BZG (Spirometer, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 868.1840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942211 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992743: Collins CPL, Collins Medical, Inc. (1999) Summary page 1.
- K030464: Gem, Model 004110, Collins Medical, Inc. (2003)

## Indications for use
The Collins EAGLE (Diffusion Spirometer)is a Pulmonary Function Test System. is intended as a configurable, non-invasive pulmonary function tester (PFT) testing system. These tests are suitable for both pediatric and adult patient testing.

Source page: https://510kreport.com/device/K030917
Methodology: https://510kreport.com/methodology