510(k) · Cleared
ClearedMiniaturized Finger Clip Pulse Oximeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonin Medical, Inc. · DQA Oximeter
Cleared on Dec 8, 1994 after a 213-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 47 later devices descend from it.
- Decided
- Dec 8, 1994
- Review
- 213 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly.
- This deviceK942248 Miniaturized Finger Clip Pulse OximeterNonin Medical, Inc. · 1994
- Descendant · cites it directly · 43 of its ownK013171 3420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002
- Descendant · 2 generations on · 42 of its ownK043528 SpirotelMir Medical Intl. Research Srl · 2005
- Descendant · 3 generations on · 40 of its ownK061712 Spirobank IIMir Medical Intl. Research Srl · 2006
- Descendant · 4 generations on · 33 of its ownK072979 Spirobank GMir Medical Intl. Research Srl · 2007
- Descendant · 5 generations on · 16 of its ownK191272 Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K0131713420 Digit Pulse Oximeter, Model 3420Bci, Inc. · 2002 · cites it directly43descendants
- K043528SpirotelMir Medical Intl. Research Srl · 2005 · 2 generations on42descendants
- K061712Spirobank IIMir Medical Intl. Research Srl · 2006 · 3 generations on40descendants
- K072979Spirobank GMir Medical Intl. Research Srl · 2007 · 4 generations on33descendants
- K191272Wearable Device, Wearable PackageCurrent Health, Ltd. · 2019 · 5 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K942248 | Miniaturized Finger Clip Pulse Oximeter | Nonin Medical, Inc. | 1994 | — |
| +1 | K013171 | 3420 Digit Pulse Oximeter, Model 3420 | Bci, Inc. | 2002 | — |
| +2 | K043528 | Spirotel | Mir Medical Intl. Research Srl | 2005 | — |
| +3 | K061712 | Spirobank II | Mir Medical Intl. Research Srl | 2006 | — |
| +4 | K072979 | Spirobank G | Mir Medical Intl. Research Srl | 2007 | — |
| +5 | K191272 | Wearable Device, Wearable Package | Current Health, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 6 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 5 | 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.
Planning a device in DQA? 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? (47)
See all 472 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K013171 (Bci, Inc., 2002) has gone furthest, with 43 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/K942248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K942248: Miniaturized Finger Clip Pulse Oximeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K942248
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