510(k) · Cleared
ClearedNonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Cleared on Aug 12, 1999 as substantially equivalent to K893221 (Nonin Medical, Inc., 1990) and 3 other predicates after a 352-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Aug 12, 1999
- Review
- 352 days
- Class
- Class II
- Product code
- CCK
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K950387 (1995). 5 ancestors in all, the oldest K893221 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950387 | Gemini | Spegas Industries, Ltd. | 1995 | — |
| −1 | K964239 | Combination Oximeter/Carbon Dioxide Gas Analyzer | Spegas Industries, Ltd. | 1997 | — |
| 0 (this device) | K982969 | Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847 | Nonin Medical, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1997 | 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? (4)
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 |
|---|---|---|---|
| * | K893221 | Model 8500 Hand Held Pulse OximeterSummary page 1…rbon Dioxide Detector are substantially equivalent to: (1) The pulse oximeter segment is substantially equivalent to the NONIN Models 8500/8500A Pulse Oximeters [S10(k)s 893221/945290]. (2) The Carbon Dioxide [CO;] Detector segment is substantially equivalent to the Nellcor Stat Cap Model N-60B [510(k) 91… | 1990 |
| * | K945290 | 8500A Pulse OximeterSummary page 1…oxide Detector are substantially equivalent to: (1) The pulse oximeter segment is substantially equivalent to the NONIN Models 8500/8500A Pulse Oximeters [S10(k)s 893221/945290]. (2) The Carbon Dioxide [CO;] Detector segment is substantially equivalent to the Nellcor Stat Cap Model N-60B [510(k) 915494].… | 1997 |
| * | K915494 | Nellcor Stat-Cap Airway CO2 Indicator, Model N-60Summary page 1…8500/8500A Pulse Oximeters [S10(k)s 893221/945290]. (2) The Carbon Dioxide [CO;] Detector segment is substantially equivalent to the Nellcor Stat Cap Model N-60B [510(k) 915494]. (3) The NONIN Model 9843, 9845, and 9847 Pulse Oximeter and CO, Detector is substantially equivalent to the two-parameter Spega… | 1993 |
| * | K964239 | Combination Oximeter/Carbon Dioxide Gas AnalyzerSummary page 1…N-60B [510(k) 915494]. (3) The NONIN Model 9843, 9845, and 9847 Pulse Oximeter and CO, Detector is substantially equivalent to the two-parameter Spegas MicroCap/NPB-75 [K964239] which likewise functions as a dual function instrument displaying CO, and SpO;. DESCRIPTION of the DEVICE: The NONIN® Pulse Ox… | 1997 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 3 other devices also cite its predicate K893221.
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.
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 NONIN® Pulse Oximeter and Carbon Dioxide Detector (Model 9840-Series) is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO₂), pulse rate, and approximate carbon dioxide (CO₂) changes in the airway of intubated patients. These functions may be used separately or simultaneously.
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/K982969 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982969: Nonin Pulse Oximeter and Carbon Dioxide Detector, Models 9843, 9845 and 9847.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982969
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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