510(k) · Cleared
ClearedGem, Model 004110
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Collins Medical, Inc. · BZG Spirometer, Diagnostic
Cleared on Mar 14, 2003 as substantially equivalent to K992743 (Collins Medical, Inc., 1999) and 1 other predicate after a 30-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Mar 14, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- BZG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K942211 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K030917Gem; Hawk; Eagle; Models 004110, 0044120, 004130Collins Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K942211 | VMAX229 Series Pulmonary/Metabolic Systems | Sensor Medics Corp. | 1994 | — |
| 0 (this device) | K030464 | Gem, Model 004110 | Collins Medical, Inc. | 2003 | — |
| +1 | K030917 | Gem; Hawk; Eagle; Models 004110, 0044120, 004130 | Collins Medical, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new BZG device
- #1 K251777 MESI mTABLET SPIROscore 13.0 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992743 | Collins CPLSummary page 1…repared: Feb. 10, 2003 C o m m o n or Usual Name GEM (Gas Exchange Module) Classification Name Spirometer, Diagnostic Predicate Devices Collins CPL - K992743 SensorMedics VMAX - K9422 11 Intended Use The GEM is intended to be used for diagnostic use in th… | 1999 |
| * | K942211 | VMAX229 Series Pulmonary/Metabolic SystemsSummary page 1…ame GEM (Gas Exchange Module) Classification Name Spirometer, Diagnostic Predicate Devices Collins CPL - K992743 SensorMedics VMAX - K9422 11 Intended Use The GEM is intended to be used for diagnostic use in the treatment of pulmonary illnesses with an inte… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030917 | Gem; Hawk; Eagle; Models 004110, 0044120, 004130 | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All BZG devicesBZG Spirometer, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BZG
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · BZG
362in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BZG
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BZG
1in 2025
MAUDE reports naming product code BZG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 121 | 0 | 1 |
| 2008 | 3 | 209 | 0 | 0 |
| 2009 | 8 | 141 | 0 | 0 |
| 2010 | 4 | 181 | 0 | 0 |
| 2011 | 6 | 278 | 0 | 1 |
| 2012 | 3 | 59 | 0 | 2 |
| 2013 | 3 | 266 | 0 | 1 |
| 2014 | 5 | 154 | 0 | 1 |
| 2015 | 5 | 273 | 0 | 1 |
| 2016 | 4 | 235 | 0 | 1 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 1 |
| 2019 | 3 | 146 | 0 | 1 |
| 2020 | 5 | 126 | 0 | 2 |
| 2021 | 1 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 3 |
| 2023 | 5 | 362 | 0 | 2 |
| 2024 | 2 | — | 1 | 3 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030464 · printed Nov 5, 2026
Cite this page
510(k) Report. “K030464: Gem, Model 004110.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030464
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026