510(k) · Cleared
Recalled · 2009Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Novametrix Medical Systems, Inc. · DQA Oximeter
Cleared on Jul 15, 1992 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 59 devices in its family, counting itself, has a Class I recall. 58 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 15, 1992
- Review
- 168 days
- Class
- Class II
- Product code
- DQA
- Recalls
- 3
- Predicates
- 0
58 later devices descend from it, 1 citing it directly. 1 of the 59 devices in this family, counting this one, has a Class I recall.
- This deviceK920379 Novametrix Model 7100 Comb. End Tidal CO2 & Pul OXNovametrix Medical Systems, Inc. · 1992
- Descendant · cites it directly · 57 of its ownK032971 Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 39 of its ownK083821 Vital Signs MonitorEdan Instruments, Inc. · 2009
- Descendant · 3 generations on · 16 of its ownK093016 Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010
- Descendant · 3 generations on · 15 of its ownK113623 Patient MonitorEdan Instruments, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 15 of its ownK042601 Capnostat 5Respironics Novametrix, Inc. · 2004 · Recalled
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K193058 SonarMed AirWave Airway Monitoring System4 generations on · 2020
Most influential descendants
Showing 5 of 58 · See all- K032971Tidal Wave SP Model 710/715 and 715Respironics Novametrix, Inc. · 2004 · cites it directly57descendants
- K083821Vital Signs MonitorEdan Instruments, Inc. · 2009 · 2 generations on39descendants
- K093016Vital Signs MonitorShenzhen Creative Industry Co., Ltd. · 2010 · 3 generations on16descendants
- K113623Patient MonitorEdan Instruments, Inc. · 2012 · 3 generations on15descendants
- K042601Capnostat 5Respironics Novametrix, Inc. · 2004 · 2 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920379 | Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX | Novametrix Medical Systems, Inc. | 1992 | — |
| +1 | K032971 | Tidal Wave SP Model 710/715 and 715 | Respironics Novametrix, Inc. | 2004 | 7 |
| +2 | K083821 | Vital Signs Monitor | Edan Instruments, Inc. | 2009 | — |
| +3 | K093016 | Vital Signs Monitor | Shenzhen Creative Industry Co., Ltd. | 2010 | — |
| +3 | K113623 | Patient Monitor | Edan Instruments, Inc. | 2012 | 2 |
| +2 | K042601 | Capnostat 5 | Respironics Novametrix, Inc. | 2004 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 1 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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.
1 device in this family has 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 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? (58)
See all 581 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032971 | Tidal Wave SP Model 710/715 and 715 | 2004 | 57 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2009 | Not classified | Z-1269-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1268-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
| Nov 19, 2009 | Not classified | Z-1287-2010 | Nonconforming Material/Component | Power cords' prongs may crack or fail -- Philips was notified that FDA is investigating whether certain types of Electri-Cord Manufacturing Company power cords used with medical devices may be defective in that the power cord's prongs may… |
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.
- K193058SonarMed AirWave Airway Monitoring SystemSonarmed, Inc. · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- Of its descendants, K032971 (Respironics Novametrix, Inc., 2004) has gone furthest, with 57 descendants of its own.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
https://510kreport.com/device/K920379 · printed Nov 5, 2026
Cite this page
510(k) Report. “K920379: Novametrix Model 7100 Comb. End Tidal CO2 & Pul OX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920379
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026