510(k) · Cleared
ClearedModel 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Aug 5, 2016 as substantially equivalent to K132402 (Nonin Medical, Inc., 2014) and 1 other predicate after a 128-day review. Its family tree reaches back 13 generations to 1993. 1 of the 85 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 5, 2016
- Review
- 128 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K931154 (1993). 83 ancestors in all, the oldest K850978 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 9 generations between
- 3 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 2 generations backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- 1 generation backK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- This deviceK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK233827 OxiWearOxiwear, Inc. · 2024
Show all 13 generations
- Root · 13 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 12 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 11 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 10 generations backK002231 LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and…Olympus Optical Co., Ltd. · 2001
- 9 generations backK011869 Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary…The Olympus Optical Co. · 2001
- 8 generations backK040684 T-Stat Microvascular Tissue Oximeter, Model 303Spectros Corporation · 2004
- 7 generations backK051257 Adult Cerebral Oximeter, Model 2040Cas Medical Systems, Inc. · 2005
- 6 generations backK061960 Fore-Sight Cerebral Oximeter Monitor, Model 2040Cas Medical Systems, Inc. · 2006
- 5 generations backK083892 Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030)Cas Medical Systems, Inc. · 2009
- 4 generations backK091452 Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030)Cas Medical Systems, Inc. · 2009
- 3 generations backK102715 Regional OximeterNonin Medical, Inc. · 2010
- 2 generations backK113215 Model 7600 Regional Oximeter System with Equanox TechnologyNonin Medical, Inc. · 2012
- 1 generation backK132402 Sensmart Model X-100 Univeral Oximetry SystemNonin Medical, Inc. · 2014 · Recalled
- This deviceK160865 Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter…Nonin Medical, Inc. · 2016
Class I recalls in this family
- K970209 Capnocheck Plus4 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K233827OxiWearOxiwear, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −12 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −11 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −10 | K002231 | LF-DP Gastrointestinal and Sigmoid Fiberscope, Accessories and Ancillary… | Olympus Optical Co., Ltd. | 2001 | — |
| −9 | K011869 | Xenf-DP Rhino-Laryngofiberscope, Its Accessories and Ancillary Equipment | The Olympus Optical Co. | 2001 | — |
| −8 | K040684 | T-Stat Microvascular Tissue Oximeter, Model 303 | Spectros Corporation | 2004 | — |
| −7 | K051257 | Adult Cerebral Oximeter, Model 2040 | Cas Medical Systems, Inc. | 2005 | — |
| −6 | K061960 | Fore-Sight Cerebral Oximeter Monitor, Model 2040 | Cas Medical Systems, Inc. | 2006 | — |
| −5 | K083892 | Fore-Sight, Model MC-2000 Series (MC-2000, MC-2010, MC2020, MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −4 | K091452 | Fore-Sight, Model MC-2000 Series (MC 2000, MC2010, MC-2020,MC2030) | Cas Medical Systems, Inc. | 2009 | — |
| −3 | K102715 | Regional Oximeter | Nonin Medical, Inc. | 2010 | — |
| −2 | K113215 | Model 7600 Regional Oximeter System with Equanox Technology | Nonin Medical, Inc. | 2012 | — |
| −1 | K132402 | Sensmart Model X-100 Univeral Oximetry System | Nonin Medical, Inc. | 2014 | 1 |
| 0 (this device) | K160865 | Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors… | Nonin Medical, Inc. | 2016 | — |
| +1 | K233827 | OxiWear | Oxiwear, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 1 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 6 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 4 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K090853 | FDA’s K090853 is Yield Tissue Sampler Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K132402 | Sensmart Model X-100 Univeral Oximetry SystemSummary page 8…imetry Sensors (Models 8100SS, 8100SM and 8100SL) and Nonin Model 8000Q2 Ear Clip Sensor cleared under K09853 (June 4, 2010), K132402 (February 21, 2014) and K080255 (May 23, 2008), respectively. The proposed and predic… | 2014 |
| * | K080255 | Nonin Medical, Inc., Model 7500 Digital Pulse OximeterSummary page 8…100SM and 8100SL) and Nonin Model 8000Q2 Ear Clip Sensor cleared under K09853 (June 4, 2010), K132402 (February 21, 2014) and K080255 (May 23, 2008), respectively. The proposed and predicate sensors utilize Nonin’s PureLight®… | 2008 |
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 |
|---|---|---|---|
| K233827 | OxiWear | 2024 | 0 |
Has anything in its family been recalled? (1 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.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 14 of the 83 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K233827 (Oxiwear, Inc., 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K132402.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 | — |
What is it indicated for?
Nonin’s Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 lb; 6100CP: pediatrics > 10 kg / 22 lb.; 6100CI: infants > 2 kg / 4 lb; and 6100CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions. It is intended for use hospitals, medical…
Read the full statement (753 words)
Nonin’s Model 6100C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6100CA: adults > 30 kg / 66 lb; 6100CP: pediatrics > 10 kg / 22 lb.; 6100CI: infants > 2 kg / 4 lb; and 6100CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Nonin’s Model 6101C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6101CA: adults > 30 kg / 66 lb; 6101CP: pediatrics > 10 kg / 22 lb.; 6101CI: infants > 2 kg / 4 lb; and 6101CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
Nonin’s Model 6102C Series single-patient use, disposable pulse oximeter sensors are indicated for non-invasive spot-checking and/or continuous monitoring of patients (6102CA: adults > 30 kg / 66 lb; 6102CP: pediatrics > 10 kg / 22 lb.; 6102CI: infants > 2 kg / 4 lb; and 6102CN: neonates < 2 kg / 4 lb and adults > 30 kg / 66 lb), who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The Model 8100AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8100AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The Model 8101AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8101AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The Model 8102AA reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients (> 30 kg / 66 lb) who are well or poorly perfused, during both motion and non-motion conditions.
The Model 8102AP reusable, finger clip sensor is intended for non-invasive spot-checking and/or continuous monitoring of pediatric patients (8 – 60 kg / 18 – 132 lb) who are well or poorly perfused, during both motion and non-motion conditions.
It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The Model 8100Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
The Model 8101Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
The Model 8102Q2 reusable, ear clip sensor is indicated for non-invasive, spot-checking and/or continuous monitoring of adult and pediatric patients (> 40 kg / 88 lb) who are well or poorly perfused, during non-motion conditions. It is intended for use in hospitals, medical facilities, Emergency Medical Service (EMS) environments, home healthcare environments, and mobile environments.
The recommended application site is the earlobe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160865 · printed Nov 4, 2026
Cite this page
510(k) Report. “K160865: Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C Series: 6100CA, 6100CP, 6100CI, 6100CN), Model 6101C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6101C Series: 6101CA, 6101CP, 6101CI, 6101CN), Model 6102C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6102C Series: 6102CA, 6102CP, 6102CI, 6102CN), Model 8100AA/8100AP Reusable, Finger Clip Pulse Oximeter Sensor, Model 8101AA/8101AP Reusable, Finger Clip Pulse Oximeter Senso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K160865
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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