510(k) · Cleared
Recalled · Class I · 2021Oximetry Interface Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Respironics, Inc. · MNS Ventilator, Continuous, Non-Life-Supporting
Cleared on Oct 4, 2011 as substantially equivalent to K102465 (Respironics, Inc., 2011) and 1 other predicate after a 140-day review. Its family tree reaches back 11 generations to 1996. 4 of the 44 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Oct 4, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- MNS
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 11 generations to K953930 (1996). 43 ancestors in all, the oldest K833786 (1983). No later device cites it as a predicate yet. 4 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 7 generations between
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 1 generation backK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK111378 Oximetry Interface KitPhilips Respironics, Inc. · 2011
Show all 11 generations
- Root · 11 generations backK953930 Virtuoso Smart Cpap SystemRespironics, Inc. · 1996
- 10 generations backK993433 Virtuoso LX Smart Cpap SystemRespironics, Inc. · 1999
- 9 generations backK012554 Remstar Auto Cpap SystemRespironics, Inc. · 2002
- 8 generations backK031460 Modification to Remstar Auto Cpap SystemRespironics, Inc. · 2003
- 7 generations backK032834 Bipap Pro 2 BI-Level SystemRespironics, Inc. · 2004
- 6 generations backK043607 Bipap Pro 2 BI-Level System with BI-FlexRespironics, Inc. · 2005
- 5 generations backK050759 Bipap AutoRespironics, Inc. · 2005 · Recalled
- 4 generations backK063830 Remstar Aflex Cpap SystemRespironics Inc., Sleep & Home Respiratory Group · 2007
- 3 generations backK091319 Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · Recalled (Class I)
- 2 generations backK092818 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Recalled (Class I)
- 1 generation backK102465 Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Recalled (Class I)
- This deviceK111378 Oximetry Interface KitPhilips Respironics, Inc. · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K953930 | Virtuoso Smart Cpap System | Respironics, Inc. | 1996 | — |
| −10 | K993433 | Virtuoso LX Smart Cpap System | Respironics, Inc. | 1999 | — |
| −9 | K012554 | Remstar Auto Cpap System | Respironics, Inc. | 2002 | — |
| −8 | K031460 | Modification to Remstar Auto Cpap System | Respironics, Inc. | 2003 | — |
| −7 | K032834 | Bipap Pro 2 BI-Level System | Respironics, Inc. | 2004 | — |
| −6 | K043607 | Bipap Pro 2 BI-Level System with BI-Flex | Respironics, Inc. | 2005 | — |
| −5 | K050759 | Bipap Auto | Respironics, Inc. | 2005 | 1 |
| −4 | K063830 | Remstar Aflex Cpap System | Respironics Inc., Sleep & Home Respiratory Group | 2007 | — |
| −3 | K091319 | Remstar Auto a-Flex | Respironics Inc., Sleep & Home Respiratory Group | 2009 | Class I |
| −2 | K092818 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2010 | Class I |
| −1 | K102465 | Bipap Avaps Ventilatory Support System | Respironics, Inc. | 2011 | Class I |
| 0 (this device) | K111378 | Oximetry Interface Kit | Philips Respironics, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 3 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 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.
4 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 MNS device
- #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 12 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 |
|---|---|---|---|
| * | K102465 | Bipap Avaps Ventilatory Support SystemSummary page 2…Interface Kit Predicate Device Namie(s) and 5 10(k) 1. Respironics BIPAP AVAPS with Oximetry numbers: Module (K 102465) 2. Respironics BiPAP AVAPS Ventilatory… | 2011 |
| * | K092818 | Bipap Avaps Ventilatory Support SystemSummary page 2…Module (K 102465) 2. Respironics BiPAP AVAPS Ventilatory Support System (K0928 18) Reason for submission: Device mfodifications and additional accessories K(11378 Respironics B… | 2010 |
| † | K041815 | LNCS Oximetry Sensors | 2004 |
| † | K090662 | Masimo Set Reusable Soft Oximetry Sensors - Adult / Pedicatrics, Model Dbi/ Dbip | 2009 |
| † | K012992 | Masimo Set Radical Pulse Oximeter with Satshare and Masimo Series of Sensors and Cables | 2001 |
| † | K053269 | Masimo Set Rad-8 Pulse Oximeter | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2021 | Class I | Z-1973-2021 | Device Design | The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the device s the air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals. |
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.
- K102465Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2011 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K092818Bipap Avaps Ventilatory Support SystemRespironics, Inc. · 2010 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K091319Remstar Auto a-FlexRespironics Inc., Sleep & Home Respiratory Group · 2009 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 13 of the 43 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All MNS devicesMNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MNS
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MNS
115in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNS
1in 2008
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MNS
1,790in 2025
MAUDE reports naming product code MNS, 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 | 4 | 90 | 2 | 9 |
| 2008 | 0 | — | 1 | 7 |
| 2009 | 4 | 92 | 0 | 8 |
| 2010 | 4 | 124 | 0 | 9 |
| 2011 | 3 | 140 | 0 | 9 |
| 2012 | 5 | 111 | 0 | 12 |
| 2013 | 3 | 115 | 0 | 18 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 50 |
| 2016 | 2 | — | 0 | 16 |
| 2017 | 1 | — | 0 | 20 |
| 2018 | 1 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 275 |
| 2020 | 0 | — | 0 | 64 |
| 2021 | 0 | — | 0 | 256 |
| 2022 | 1 | — | 0 | 2,514 |
| 2023 | 1 | — | 0 | 1,320 |
| 2024 | 1 | — | 0 | 1,571 |
| 2025 | 0 | — | 0 | 1,790 |
| 2026 | 3 | 269 | 1 (1) | — |
What is it indicated for?
The Oximerry Module can be used with Philips Respironics BiPAP C Series (BiPAP AVAPS and BiPAP SIT) ventilators to measure functional oxygen saturation of arterial hemoglobin (%Sp02) and pulse rate for adult and pediatric patients. The Oximetry module may be used in a hospital or home care environment.
The Philips Respironics BiPAP C-Series Ventilatory System (BiPAP AVAPS and BiPAP SIT) is intended to provide non-invasive Ventilatory support to treat adult and pediatric (> 7 years of ages; > I8 kg) patients with Obstructive Sleep Apnea (OSA) and Respiratory Insufficiency. The Respironics BiPAP C-Series Ventilatory Support System may be used in the hospital or home.
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/K111378 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111378: Oximetry Interface Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111378
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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