510(k) Report

510(k) · Cleared

Recalled · 2009

Provent Nasal Cannula

K080983510(k) TraditionalCleared Aug 7, 2008122-day reviewClass II21 CFR 868.2375Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ventus Medical, Inc. · MNR Ventilatory Effort Recorder

Cleared on Aug 7, 2008 as substantially equivalent to K051313 (Salter Labs, 2005) and 3 other predicates after a 122-day review. Its family tree reaches back 3 generations to 1992. It has been recalled once.

Decided
Aug 7, 2008
Review
122 days
Class
Class II
Product code
MNR
Recalls
1
Predicates
4

Its longest line of descent runs back 3 generations to K913396 (1992). 7 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor1998: 2 other ancestors1997: 1 other ancestorK913396 · Cannula Style Thermocouples · Pro-Tech, Inc. · 1992K982293 · Pressure Transducer Airflow Sensor · Pro-Tech Services, Inc. · 1998K051313 · BI-Naps Nasal Airflow and Snore Transducer · Salter Labs · 200519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor K051313 · BI-Naps Nasal Airflow and Snore Transducer · Salter Labs · 2005K982293 · Pressure Transducer Airflow Sensor · Pro-Tech Services, Inc. · 1998K913396 · Cannula Style Thermocouples · Pro-Tech, Inc. · 19920
  1. Root · 3 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
  2. 2 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
  3. 1 generation backK051313 BI-Naps Nasal Airflow and Snore TransducerSalter Labs · 2005
  4. This deviceK080983 Provent Nasal CannulaVentus Medical, Inc. · 2008
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K913396Cannula Style ThermocouplesPro-Tech, Inc.1992—
−2K982293Pressure Transducer Airflow SensorPro-Tech Services, Inc.1998—
−1K051313BI-Naps Nasal Airflow and Snore TransducerSalter Labs2005—
0 (this device)K080983Provent Nasal CannulaVentus Medical, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199820
200510
FIG. 1 — Lineage of K080983, 1992–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 MNR? 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 MNR device

  1. #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K051313BI-Naps Nasal Airflow and Snore Transducer
Summary page 1
…Product Code MNR) Predicate Device: Predicate devices included in the 510(k) Notification are as follows: K,051313, Salter Labs Bi-NAPS Nasal Airflow and Snore Transducer K984431, B…
Salter Labs2005—
*K984431Ultima Airflow Pressure Sensor
Summary page 1
…are as follows: K,051313, Salter Labs Bi-NAPS Nasal Airflow and Snore Transducer K984431, Braebon Medical Ultima Airflow Sensor K971501, Bio-logic Airflow Pressure Transducer…
Braebon Medical Corp.1998—
*K971501Sleepscan Airflow Pressure Transducer
Summary page 1
…asal Airflow and Snore Transducer K984431, Braebon Medical Ultima Airflow Sensor K971501, Bio-logic Airflow Pressure Transducer K053063, Pro-Flow Multipurpose Cannula Device Description: The…
Bio-Logic Systems Corp.1997—
*K053063Pro-Flow Multipurpose Cannula
Summary page 1
…K984431, Braebon Medical Ultima Airflow Sensor K971501, Bio-logic Airflow Pressure Transducer K053063, Pro-Flow Multipurpose Cannula Device Description: The Provent Nasal Cannula was developed to transmit pressure signals from th…
Pro-Tech Services, Inc.2005—

Also cleared against K051313: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 3, 2009Not classifiedZ-2435-2010Labeling mix-upsThe catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
  • None of the 7 ancestors has a recall.
  • 2 other devices also cite its predicate K051313.

How does its category compare?

All MNR devices

MNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · MNR

10in 2025

2007: 62008: 142009: 82011: 92012: 12013: 42014: 22015: 42016: 32017: 42018: 32019: 82020: 52021: 32022: 72023: 62024: 62025: 102026 (partial year): 5
2007high 14 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNR

165in 2025

2007: 124 days median2008: 118 days median2009: 89 days median2011: 90 days median2013: 161 days median2015: 229 days median2016: 281 days median2017: 275 days median2018: 147 days median2019: 383 days median2020: 192 days median2021: 137 days median2022: 266 days median2023: 183 days median2024: 217 days median2025: 165 days median2026 (partial year): 227 days median
2007high 383 (2019) · low 89 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNR

1in 2021

2007: 22009: 12011: 12021: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNR

43in 2025

2007: 12010: 12011: 12012: 12014: 12015: 42016: 102017: 42018: 22019: 32020: 52021: 52022: 42023: 132024: 112025: 43
2007high 43 (2025) · low 0 (2008)2025

MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007612421
20081411800
200988910
20100—01
201199011
20121—01
2013416100
20142—01
2015422904
20163281010
2017427504
2018314702
2019838303
2020519205
2021313715
2022726604
20236183013
20246217011
202510165043
202652271—

What is it indicated for?

The Provent Nasal Cannula is indicated for the transmission of respiratory airflow signals between the ProventTM Professional Sleep Apnea Therapy device and the pressure transducers used with physiologic recorders during sleep studies.

Indications for use as stated in the FDA summary.

Also cleared against K051313

2 other devices cite the same predicate.

  • K151874BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow…Salter Labs · 2016
  • K082853Clinical Oxygen Dose Recorder (Codr), Model 300-CRInspired Technologies, Inc. · 2009

More from Ventus Medical, Inc.

5 FDA decisions under this applicant name. See the company

  • K120665Invent Snoring DeviceVentus Medical, Inc. · 2012
  • K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea Therapy (Provent 50)Ventus Medical, Inc. · 2010
  • K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc. · 20091 recall
  • K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc. · 2008

Recent decisions in MNR

The MNR category page

  • K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbH · 2026
  • K254042WatchPAT SWItamar Medical, Ltd. · 2026
  • K260050WRAP SystemHuneo, LLC · 2026
  • K253148RX-1 SleepVivaquant, Inc. Dba Rhythm Express · 2026
  • K252628CassieWesper, Inc. · 2026

https://510kreport.com/device/K080983 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080983: Provent Nasal Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080983

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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