510(k) · Cleared
ClearedUnimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Unimed Medical Supplies, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Mar 4, 2021 as substantially equivalent to K192446 (Beijing Kingst Commercial & Trade Co., Ltd., 2020) after a 59-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- Mar 4, 2021
- Review
- 59 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K920379 (1992). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK920379 Novametrix Model 7100 Comb. End Tidal CO2 & Pul OXNovametrix Medical Systems, Inc. · 1992 · Recalled
- 3 generations backK032971 Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · Recalled
- 2 generations backK042601 Capnostat 5Respironics Novametrix, Inc. · 2004 · Recalled
- 1 generation backK192446 CO2 Mainstream ModuleBeijing Kingst Commercial & Trade Co., Ltd. · 2020
- This deviceK210019 Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream…Unimed Medical Supplies, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K920379 | Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX | Novametrix Medical Systems, Inc. | 1992 | 3 |
| −3 | K032971 | Tidal Wave SP Model 710/715 and 715 | Respironics Novametrix, Inc. | 2004 | 7 |
| −2 | K042601 | Capnostat 5 | Respironics Novametrix, Inc. | 2004 | 1 |
| −1 | K192446 | CO2 Mainstream Module | Beijing Kingst Commercial & Trade Co., Ltd. | 2020 | — |
| 0 (this device) | K210019 | Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model… | Unimed Medical Supplies, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 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 CCK? 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 CCK device
- #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K192446 | CO2 Mainstream ModuleSummary page 4…er, Gas, Carbon-Dioxide, Gaseous-Phase Regulation Number: 21 CFR 868.1400 Product Code: CCK Predicate Device : 510(k) Number: K192446 Device Name: CO2 Mainstream Module Manufacturer: Beijing Kingst Commercial & Trade Co.,Ltd. Desc… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 4 companies; a new generation was cleared every 12.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
How does its category compare?
All CCK devicesCCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · CCK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · CCK
169in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CCK
1in 2022
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · CCK
1,259in 2025
MAUDE reports naming product code CCK, 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 | 5 | 56 | 0 | 7 |
| 2008 | 3 | 248 | 1 | 20 |
| 2009 | 3 | 101 | 19 | 21 |
| 2010 | 3 | 125 | 4 | 12 |
| 2011 | 2 | — | 14 | 18 |
| 2012 | 7 | 150 | 3 | 13 |
| 2013 | 4 | 132 | 2 (1) | 28 |
| 2014 | 9 | 166 | 0 | 51 |
| 2015 | 5 | 105 | 1 | 114 |
| 2016 | 2 | — | 0 | 88 |
| 2017 | 5 | 134 | 0 | 58 |
| 2018 | 6 | 296 | 5 | 63 |
| 2019 | 7 | 261 | 7 (7) | 141 |
| 2020 | 4 | 188 | 1 | 2,302 |
| 2021 | 4 | 227 | 0 | 2,272 |
| 2022 | 3 | 226 | 1 | 2,475 |
| 2023 | 4 | 555 | 0 | 1,637 |
| 2024 | 3 | 592 | 0 | 1,216 |
| 2025 | 3 | 169 | 0 | 1,259 |
| 2026 | 3 | 224 | 0 | — |
What is it indicated for?
The CO2 Mainstream Module is intended to provide carbon dioxide monitoring to a host monitoring system during anesthesia/recovery in Emergency Medicine/Transport or Respiratory care.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K210019 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210019: Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210019
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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