510(k) · Cleared
ClearedGem-6, with Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diamond Electro-Tech, Inc. · DRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Cleared on Jan 8, 1986 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 12 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Jan 8, 1986
- Review
- 71 days
- Class
- Class II
- Product code
- DRY
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 1 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- This deviceK854357 Gem-6, with ComponentsDiamond Electro-Tech, Inc. · 1986
- Descendant · cites it directly · 10 of its ownK972962 3M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · Recalled
- Descendant · 2 generations on · 4 of its ownK110957 M4 MonitorSpectrum Medical, Llp · 2011
- Descendant · 3 generations on · 3 of its ownK173591 Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018
- Descendant · 2 generations on · 3 of its ownK090147 Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · Recalled
- Descendant · 4 generations on · 2 of its ownK181942 Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K9729623M Cdi Blood Parameter Monitoring System 5003M Company · 1997 · cites it directly10descendants
- K110957M4 MonitorSpectrum Medical, Llp · 2011 · 2 generations on4descendants
- K173591Quantum Diagnostic Module, Quantum Diagnostic Module - No GasSpectrum Medical, Ltd. · 2018 · 3 generations on3descendants
- K090147Blood Monitoring Unit, Model Bmu 40Maquet Cardiopulmonary, AG · 2009 · 2 generations on3descendants
- K181942Quantum Ventilation ModuleSpectrum Medical, Ltd. · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K854357 | Gem-6, with Components | Diamond Electro-Tech, Inc. | 1986 | — |
| +1 | K972962 | 3M Cdi Blood Parameter Monitoring System 500 | 3M Company | 1997 | 26 |
| +2 | K110957 | M4 Monitor | Spectrum Medical, Llp | 2011 | — |
| +3 | K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical, Ltd. | 2018 | — |
| +2 | K090147 | Blood Monitoring Unit, Model Bmu 40 | Maquet Cardiopulmonary, AG | 2009 | 1 |
| +4 | K181942 | Quantum Ventilation Module | Spectrum Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 1 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. 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 DRY device
- #1 K234065 CDI OneView Monitoring Systemscore 5.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 111 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972962 | 3M Cdi Blood Parameter Monitoring System 500 | 1997 | 10 |
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- Of its descendants, K972962 (3M Company, 1997) has gone furthest, with 10 descendants of its own.
How does its category compare?
All DRY devicesDRY Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DRY
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DRY
88in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRY
134in 2025
MAUDE reports naming product code DRY, 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 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 1 |
| 2009 | 2 | — | 0 | 2 |
| 2010 | 0 | — | 6 | 1,070 |
| 2011 | 2 | — | 14 | 2,268 |
| 2012 | 1 | — | 5 | 167 |
| 2013 | 0 | — | 0 | 157 |
| 2014 | 2 | — | 0 | 156 |
| 2015 | 0 | — | 1 | 231 |
| 2016 | 0 | — | 0 | 240 |
| 2017 | 1 | — | 0 | 61 |
| 2018 | 3 | 88 | 0 | 165 |
| 2019 | 0 | — | 0 | 63 |
| 2020 | 1 | — | 1 | 35 |
| 2021 | 1 | — | 0 | 42 |
| 2022 | 0 | — | 0 | 37 |
| 2023 | 0 | — | 0 | 41 |
| 2024 | 1 | — | 0 | 72 |
| 2025 | 0 | — | 0 | 134 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K854357 · printed Nov 6, 2026
Cite this page
510(k) Report. “K854357: Gem-6, with Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K854357
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026