510(k) · Cleared
ClearedHygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hygia Health Services, Inc. · NLF Oximeter, Reprocessed
Cleared on Sep 10, 2004 as substantially equivalent to K012891 (Nellcor Puritan Bennett, Inc., 2002) and 1 other predicate after a 63-day review. Its family tree reaches back 5 generations to 1997. 2 later devices descend from it.
- Decided
- Sep 10, 2004
- Review
- 63 days
- Class
- Class II
- Product code
- NLF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K962603 (1997). 10 ancestors in all, the oldest K863784 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 4 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 3 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 2 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 1 generation backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- This deviceK041867 Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a…Hygia Health Services, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080424 Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858…Hygia Health Services, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK101280 Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC · 2010
Most influential descendants
Showing 2 of 2 · See all- K080424Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862, HHS-1860 and…Hygia Health Services, Inc. · 2008 · cites it directly1descendant
- K101280Midwestern Reprocessing Center Reprocessed Pulse Oximeter ProbeMidwest Reprocessing Center, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −4 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −3 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −2 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −1 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| 0 (this device) | K041867 | Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a… | Hygia Health Services, Inc. | 2004 | — |
| +1 | K080424 | Hygia Health Services Reprocessed LNCS Sensors, Models HHS-1858, HHS-1862… | Hygia Health Services, Inc. | 2008 | — |
| +1 | K101280 | Midwestern Reprocessing Center Reprocessed Pulse Oximeter Probe | Midwest Reprocessing Center, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables… | 2002 |
| * | K863784 | Nellcor N-200 (Pulse Oximeter)Summary page 1…Hygia Health Service's 5 10(k) 012715 Nellcor Puritan Bennett, Inc. 5 10(k) KO 12891 Neilcor Puritan Bennett, Inc. 5 10(k) K863784 Device Description: The Hygia Health Services reprocessed pulse Oximeter sensors are non-invasive sensor… | 1986 |
What descends from it? (2)
2 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 7 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K080424 (Hygia Health Services, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 33 other devices also cite its predicate K012891.
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 as a non-invasive method to provide continuous SpO2 monitoring and pulse rate.
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/K041867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041867: Hygia Health Services Reprocessed Oximax Sensors Model # HHS-Max-a, HHS-Max-AL, HHS-Max-N.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041867
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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