510(k) · Cleared
ClearedDatex-Ohmeda Oxy-Afr Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Datex-Ohmeda · NLF Oximeter, Reprocessed
Cleared on Jun 29, 2005 as substantially equivalent to K021265 (Datex-Ohmeda, 2002) and 1 other predicate after a 253-day review. Its family tree reaches back 4 generations to 2001. 2 of the 16 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 29, 2005
- Review
- 253 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010463 (2001). 15 ancestors in all, the oldest K941381 (1994). No later device cites it as a predicate yet. 2 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK010463 Datex-Ohmeda Oxygen Saturation Module, M-Osat and AccessoiresDatex-Ohmeda, Inc. · 2001 · Recalled
- 3 generations backK011670 Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with…Datex-Ohmeda · 2001 · Recalled
- 2 generations backK021955 Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900…Datex-Ohmeda, Inc. · 2002 · Recalled (Class I)
- 1 generation backK040831 Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Recalled (Class I)
- This deviceK042891 Datex-Ohmeda Oxy-Afr SensorDatex-Ohmeda · 2005
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010463 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessoires | Datex-Ohmeda, Inc. | 2001 | 1 |
| −3 | K011670 | Datex-Ohmeda Oxygen Saturation Module, M-Osat and Accessories (with… | Datex-Ohmeda | 2001 | 1 |
| −2 | K021955 | Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series… | Datex-Ohmeda, Inc. | 2002 | Class I |
| −1 | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500 | Datex-Ohmeda, Inc. | 2004 | Class I |
| 0 (this device) | K042891 | Datex-Ohmeda Oxy-Afr Sensor | Datex-Ohmeda | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 3 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 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.
2 devices in this family have a Class I recall. 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? (2)
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 |
|---|---|---|---|
| * | K021265 | Datex-Ohmeda Hmef 500Summary page 2…3) The Datex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda OXY-AF SENSOR (K021265). DEVICE DESCRIPTION as required by 807.92(a)(4) This OXY-AFR sensor has a sensor head, consisting of a red LED and tw… | 2002 |
| * | K040831 | Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Summary page 3…tex-Ohmeda OXY-AFR Sensor is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmcda OXY-AF SENSOR (K04083 1). The Datex-Ohmeda OXY-AFR Sensor has the following similarities to the Datex-Ohmeda OXY-AF SENSOR predic… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K040831Datex-Ohmeda Trusat Pulse Oximeter and Accessories, Model 3500Datex-Ohmeda, Inc. · 2004 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- K021955Trutrak Plus Enhancements to the Datex-Ohmeda 3800 Series & 3900 Series Oximeters & AccessoriesDatex-Ohmeda, Inc. · 2002 · 2 generations back · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 15 ancestors have a recall of any class; 2 have a Class I recall.
- 3 other devices also cite its predicate K021265.
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 reprocessed AliFit Oximetry sensor, OXY-AFR, is a single-patient-use, adhesive sensor for short-term or long-term monitoring of functional oxygen saturation and pulse rate. The device is indicated for use by qualified medical personnel 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/K042891 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042891: Datex-Ohmeda Oxy-Afr Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042891
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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