510(k) · Cleared
ClearedNPB-190 Pulse Oximeter (NPB-190)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nellcor Puritan Bennett, Inc. · DQA Oximeter
Cleared on Aug 25, 1997 as substantially equivalent to K963707 (Nellcor Puritan Bennett, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1993. 1 later device descends from it.
- Decided
- Aug 25, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K915699 (1993). 4 ancestors in all, the oldest K863784 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915699 Nellcor Portable Pulse Oximeter Model N-20Nellcor, Inc. · 1993
- 1 generation backK963707 Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996
- This deviceK971946 NPB-190 Pulse Oximeter (NPB-190)Nellcor Puritan Bennett, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK052544 Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K052544Pulse Oximeter Adapter CablesAmerican I.V. Products, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915699 | Nellcor Portable Pulse Oximeter Model N-20 | Nellcor, Inc. | 1993 | — |
| −1 | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40) | Nellcor Puritan Bennett, Inc. | 1996 | — |
| 0 (this device) | K971946 | NPB-190 Pulse Oximeter (NPB-190) | Nellcor Puritan Bennett, Inc. | 1997 | — |
| +1 | K052544 | Pulse Oximeter Adapter Cables | American I.V. Products, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Summary page 1…eir currently published accuracy specifications with the NPB-190. The predicate devices are as follows: 1. NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett Inc., K963707 2. Nellcor® N-200 Pulse Oximeter, Nellcor Puritan Bennett Inc., K863784 3. BCI 3304 Oximeter, BCI International Inc., K962156 10… | 1996 |
| * | K863784 | Nellcor N-200 (Pulse Oximeter)Summary page 1…edicate devices are as follows: 1. NPB-40 Handheld Pulse Oximeter, Nellcor Puritan Bennett Inc., K963707 2. Nellcor® N-200 Pulse Oximeter, Nellcor Puritan Bennett Inc., K863784 3. BCI 3304 Oximeter, BCI International Inc., K962156 1018 Section 16.e Device Description The NPB-190 Pulse Ox… | 1986 |
| * | K962156 | 3304 Pulse OximeterSummary page 1…lse Oximeter, Nellcor Puritan Bennett Inc., K963707 2. Nellcor® N-200 Pulse Oximeter, Nellcor Puritan Bennett Inc., K863784 3. BCI 3304 Oximeter, BCI International Inc., K962156 1018 Section 16.e Device Description The NPB-190 Pulse Oximeter is designed for continuous, non-invasive monito… | 1996 |
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 |
|---|---|---|---|
| K052544 | Pulse Oximeter Adapter Cables | 2006 | 0 |
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 3.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K052544 (American I.V. Products, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K963707.
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 | — |
What is it indicated for?
The intended use of the NPB-190 Pulse Oximeter is the continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO,) and pulse rate. For use with neonatal, pediatric and adult patients, in hospital, hospital-type, intra-hospital transport and home environments. For prescription use only.
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/K971946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971946: NPB-190 Pulse Oximeter (NPB-190).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971946
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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