510(k) · Cleared
Recalled · 2008Vanguard Reprocessed Pulse Oximeter Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vanguard Medical Concepts, Inc. · NLF Oximeter, Reprocessed
Cleared on Oct 4, 2002 after a 437-day review. The FDA summary names its predicate without a number. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 4, 2002
- Review
- 437 days
- Class
- Class II
- Product code
- NLF
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK012344 Vanguard Reprocessed Pulse Oximeter SensorsVanguard Medical Concepts, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK211138 Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter…Stryker Sustainability Solutions · 2022
Most influential descendants
Showing 1 of 1 · See all- K211138Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)…Stryker Sustainability Solutions · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012344 | Vanguard Reprocessed Pulse Oximeter Sensors | Vanguard Medical Concepts, Inc. | 2002 | — |
| +1 | K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor… | Stryker Sustainability Solutions | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 NLF? 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 NLF device
- #1 K241758 Reprocessed RD SET Adt Pulse Oximeter Sensor…score 14.5 · 22 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 |
|---|---|---|---|
| * | — | Mallinckrodt, Inc., Nellcor Oxisensor® II Sensors Named without a submission number |
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 |
|---|---|---|---|
| K211138 | Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L)… | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 11, 2008 | Not classified | Z-1663-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| Mar 11, 2008 | Not classified | Z-1664-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
| Mar 11, 2008 | Not classified | Z-1683-2008 | Process control | Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K211138 (Stryker Sustainability Solutions, 2022) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NLF devicesNLF Oximeter, Reprocessed: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NLF
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · NLF
146in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NLF
3in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NLF
3in 2025
MAUDE reports naming product code NLF, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 3 | 7 |
| 2009 | 3 | 214 | 0 | 3 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 3 | 146 | 0 | 4 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 2 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The sensor is indicated for use in continuous noninvasive arterial oxygen saturation and
pulse rate monitoring.
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/K012344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012344: Vanguard Reprocessed Pulse Oximeter Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012344
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026