510(k) · Cleared
ClearedEnvitec Oxipen Pulse Oximeter and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Envitec-Wismar GmbH · DQA Oximeter
Cleared on May 2, 2007 as substantially equivalent to K963707 (Nellcor Puritan Bennett, Inc., 1996) after a 100-day review. Its family tree reaches back 2 generations to 1993. 15 later devices descend from it.
- Decided
- May 2, 2007
- Review
- 100 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915699 (1993). 15 later devices descend from it, 2 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 deviceK070193 Envitec Oxipen Pulse Oximeter and AccessoriesEnvitec-Wismar GmbH · 2007
- Descendant · cites it directly · 13 of its ownK113165 Mini-MedicAthena Gtx · 2012
- Descendant · 2 generations on · 12 of its ownK190792 BB-613WPBiobeat Technologies, Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK212153 Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022
- Descendant · 4 generations on · 2 of its ownK242018 UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024
- Descendant · 3 generations on · 2 of its ownK222658 Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113165Mini-MedicAthena Gtx · 2012 · cites it directly13descendants
- K190792BB-613WPBiobeat Technologies, Ltd. · 2019 · 2 generations on12descendants
- K212153Biobeat Platform, BB-613WP PatchBiobeat Technologies, Ltd. · 2022 · 3 generations on5descendants
- K242018UbiqVue™ 2A Multi-parameter System (UX2550)Lifesignals, Inc. · 2024 · 4 generations on2descendants
- K222658Accurate 24 Non-invasive blood pressure monitorAccurate Meditech, Inc. · 2023 · 3 generations on2descendants
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) | K070193 | Envitec Oxipen Pulse Oximeter and Accessories | Envitec-Wismar GmbH | 2007 | — |
| +1 | K113165 | Mini-Medic | Athena Gtx | 2012 | — |
| +2 | K190792 | BB-613WP | Biobeat Technologies, Ltd. | 2019 | — |
| +3 | K212153 | Biobeat Platform, BB-613WP Patch | Biobeat Technologies, Ltd. | 2022 | — |
| +4 | K242018 | UbiqVue™ 2A Multi-parameter System (UX2550) | Lifesignals, Inc. | 2024 | — |
| +3 | K222658 | Accurate 24 Non-invasive blood pressure monitor | Accurate Meditech, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K963707 | Nellcor Puritan Bennett NPB-40 Handheld Pulse (NPB-40)Summary page 1…II (3) Predicate Device(s): Substantial Equivalence to: K Number Model Manufacturer K963707 NBP 40 Handheld Pulse Nellcor Puritan Bennett Oximeter… | 1996 |
What descends from it? (15)
See all 152 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113165 (Athena Gtx, 2012) has gone furthest, with 13 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. 2007, 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?
The EnviteC OxiPen Pulse Oximeter is intended for noninvasive spot-check measurement of functional oxygen saturation of arterial hemoglobin (SpO2), and pulse rate (measured by SpO2 sensor accessories).
The monitor is intended for use on adult and pediatric patients in hospitals, hospital-type facilities, mobile, and home environments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070193: Envitec Oxipen Pulse Oximeter and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070193
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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