# K030464: Gem, Model 004110

- Pathway: 510(k) (Special)
- Applicant: Collins Medical, Inc.
- Decided: Mar 14, 2003 after 30 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: 1 generation back to K942211 (1994). 2 ancestors in all.
1 later device descends from it; 1 cites 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)
- K992743: Collins CPL, Collins Medical, Inc. (1999) Summary page 1.
- K942211: VMAX229 Series Pulmonary/Metabolic Systems, Sensor Medics Corp. (1994) Summary page 1.

## Most influential descendants
- K030917: Gem; Hawk; Eagle; Models 004110, 0044120, 004130 (2003), 0 descendants of its own

## Indications for use
The Collins GEM (Gas Exchange Modu1e)is a Pulmonary Function Test System. is intended ast a configurable, non-invasive pulmonary function tester (PFT). These tests are suitable for both pediatric: and adult patient testing. Compatible with the Collins‘ Body Plethysmograph as an optional module. This is the same intended use as the previously cleared GS Modular Pulmonary Function Test System and CPL Comprehensive Pulmonary Laboratory.

Source page: https://510kreport.com/device/K030464
Methodology: https://510kreport.com/methodology