510(k) · Cleared
ClearedNellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)
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 Dec 13, 1996 as substantially equivalent to K915699 (Nellcor, Inc., 1993) after an 88-day review. Its family tree reaches back 1 generation to 1993. 58 later devices descend from it.
- Decided
- Dec 13, 1996
- Review
- 88 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915699 (1993). 58 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK915699 Nellcor Portable Pulse Oximeter Model N-20Nellcor, Inc. · 1993
- This deviceK963707 Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Nellcor Puritan Bennett, Inc. · 1996
- Descendant · cites it directly · 28 of its ownK051352 Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005
- Descendant · 2 generations on · 19 of its ownK072581 PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008
- Descendant · cites it directly · 15 of its ownK070193 Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH · 2007
- Descendant · 2 generations on · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 3 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K051352Oximax NPB-40 Handheld Pulse OximeterNellcor Puritan Bennett, Inc. · 2005 · cites it directly28descendants
- K072581PM-60 Pulse OximeterShenzhen Mindray Bio-Medical Electronics Co., Ltd. · 2008 · 2 generations on19descendants
- K070193Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH · 2007 · cites it directly15descendants
- K113165Mini-MedicAthena Gtx · 2012 · 2 generations on13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 3 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915699 | Nellcor Portable Pulse Oximeter Model N-20 | Nellcor, Inc. | 1993 | — |
| 0 (this device) | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40) | Nellcor Puritan Bennett, Inc. | 1996 | — |
| +1 | K051352 | Oximax NPB-40 Handheld Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2005 | — |
| +2 | K072581 | PM-60 Pulse Oximeter | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2008 | — |
| +1 | K070193 | Envitec Oxipen Pulse Oximeter and Accessories | Envitec-Wismar GmbH | 2007 | — |
| +2 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +3 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 5 | 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? (1)
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 |
|---|---|---|---|
| * | K915699 | Nellcor Portable Pulse Oximeter Model N-20Summary page 1…'s indications for use are also equivalent to the intended use of the N-20 Handheld Pulse Oximeter. The N-20 Handheld Pulse Oximeter was originally cleared under 510(k) #K915699 on May 27, 1993. 4. DEVICE DESCRIPTION The NPB-40 Handheld Pulse Oximeter is a light-weight, portable, hand-held noninvasive pu… | 1993 |
What descends from it? (58)
See all 585 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?
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 NPB-40 Handheld Pulse Oximeter is intended for non-invasive spot-check measurement of functional arterial oxygen saturation (Sp02) and pulse rate of adults, pediatric, and neonatal patients in hospital, emergency, transport, and mobile environments, as well as in the home. The NPB-40 is for attended monitoring only and is intended to be used under the direct observation of a qualified health care provider.
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/K963707 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963707: Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963707
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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