510(k) Report

510(k) · Cleared

Cleared

Nasal-Air Critical Care

K031896510(k) TraditionalCleared Jan 14, 2004209-day reviewClass II21 CFR 868.5895

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

Innomed Technologies · MNS Ventilator, Continuous, Non-Life-Supporting

Cleared on Jan 14, 2004 as substantially equivalent to K982454 (Respironics, Inc., 1998) and 3 other predicates after a 209-day review. Its family tree reaches back 4 generations to 1983.

Decided
Jan 14, 2004
Review
209 days
Class
Class II
Product code
MNS
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K833786 (1983). 13 ancestors in all, the oldest K811102 (1981). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2003: 1 other ancestor2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1988: 1 other ancestor1981: 1 other ancestorK833786 · Microprocessor Ventilator 7200 · Puritan Bennett Corp. · 1983K951264 · Bipap Model S/T-D · Respironics, Inc. · 1996K955324 · Bipap S/T-D 30 System · Respironics, Inc. · 1996K982454 · Bipap Vision Ventilatory Support · Respironics, Inc. · 1998 · recalled198019851990199520002005
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors K982454 · Bipap Vision Ventilatory Support · Respironics, Inc. · 1998 · recalledK955324 · Bipap S/T-D 30 System · Respironics, Inc. · 1996K951264 · Bipap Model S/T-D · Respironics, Inc. · 1996K833786 · Microprocessor Ventilator 7200 · Puritan Bennett Corp. · 19830
  1. Root · 4 generations backK833786 Microprocessor Ventilator 7200Puritan Bennett Corp. · 1983
  2. 3 generations backK951264 Bipap Model S/T-DRespironics, Inc. · 1996
  3. 2 generations backK955324 Bipap S/T-D 30 SystemRespironics, Inc. · 1996
  4. 1 generation backK982454 Bipap Vision Ventilatory SupportRespironics, Inc. · 1998 · Recalled
  5. This deviceK031896 Nasal-Air Critical CareInnomed Technologies · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K833786Microprocessor Ventilator 7200Puritan Bennett Corp.1983—
−3K951264Bipap Model S/T-DRespironics, Inc.1996—
−2K955324Bipap S/T-D 30 SystemRespironics, Inc.1996—
−1K982454Bipap Vision Ventilatory SupportRespironics, Inc.19982
0 (this device)K031896Nasal-Air Critical CareInnomed Technologies2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198810
199110
199510
199810
199910
200110
200210
200310
FIG. 1 — Lineage of K031896, 1983–2004Source: 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 MNS? 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. #1 K251661 Mariana Minerva; Mariana Nimbusscore 14.2 · 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
*K982454Bipap Vision Ventilatory Support
Summary page 1
…1. Ventilator, Continuous, Non-Life Supporting 2. Accessory to Continuous Ventilator Predicate Devices: K982454, BiPAP Vision Ventilatory Support System and Whisper Swivel exhalation port as cleared with…
Respironics, Inc.19982
*K003075Knightstar 330 Ventilator
Summary page 1
…Swivel exhalation port as cleared with use for this ventilator; Manufacturer: Respironics Inc. K003075, Knightstar 330 Ventilator and Breeze Sleepgear Interface with Nasal Pillows Assembly as…
Mallinckrodt, Inc.20011
*K022465Modification to Nasal-Aire
Summary page 1
…ce recommended for use by the manufacturer with this ventilator; Manufacturer: Puritan-Bennett. K022465, Nasal-Aire II, Innomed Technologies K023244, Mirage Full Face Mask Series, ResMed, Inc.…
Innomed Technologies2003—
*K023244Mirage Full Face Mask Series 2
Summary page 1
…h this ventilator; Manufacturer: Puritan-Bennett. K022465, Nasal-Aire II, Innomed Technologies K023244, Mirage Full Face Mask Series, ResMed, Inc. Device Description - Nasal-Aire Criticial Care is ventilator interface accessory in…
Resmed, Ltd.2002—

Also cleared against K982454: 6 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)

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 21 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • 2 of the 13 ancestors have a recall of any class.
  • 6 other devices also cite its predicate K982454.

How does its category compare?

All MNS devices

MNS Ventilator, Continuous, Non-Life-Supporting: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNS

1in 2024

2007: 42009: 42010: 42011: 32012: 52013: 32016: 22017: 12018: 12022: 12023: 12024: 12026 (partial year): 3
2007high 5 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNS

115in 2013

2007: 90 days median2009: 92 days median2010: 124 days median2011: 140 days median2012: 111 days median2013: 115 days median2026 (partial year): 269 days median
2007high 269 (2026) · low 90 (2007)2026

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

Recalls per year · MNS

1in 2008

2007: 22008: 12026 (partial year): 1, 1 Class I
2007high 2 (2007) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MNS

1,790in 2025

2007: 92008: 72009: 82010: 92011: 92012: 122013: 182014: 52015: 502016: 162017: 202018: 222019: 2752020: 642021: 2562022: 2,5142023: 1,3202024: 1,5712025: 1,790
2007high 2,514 (2022) · low 5 (2014)2025

MAUDE reports naming product code MNS, 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
200749029
20080—17
200949208
2010412409
2011314009
20125111012
20133115018
20140—05
20150—050
20162—016
20171—020
20181—022
20190—0275
20200—064
20210—0256
20221—02,514
20231—01,320
20241—01,571
20250—01,790
202632691 (1)—

What is it indicated for?

Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Indications for use as stated in the FDA summary.

Also cleared against K982454

6 other devices cite the same predicate.

  • K212031F&P 850 AirSpiral Adult NIV and NHF Circuit KitFisher & Paykel Healthcare, Ltd. · 2022
  • K082660V60 Ventilator, Model V8000Respironics California, Inc. · 20093 Class I recalls
  • K072885Carina System, Model 8419350; Carina Basic Device, Model 5704110Draeger Medical AG & Co. KG · 20081 Class I recall
  • K072450Esprit Ventilator Auto-Trak Sensitivity Option, Model V1000Respironics California, Inc. · 2007
  • K053168Bipap FocusRespironics (Ireland) Limited · 20061 recall
  • K023350Esprit Ventilator with Respiratory MechanicsRespironics California, Inc. · 20021 Class I recall

More from Innomed Technologies

3 FDA decisions under this applicant name. See the company

  • K050171IT Nasal MaskInnomed Technologies · 2005
  • K022465Modification to Nasal-AireInnomed Technologies · 2003

Recent decisions in MNS

The MNS category page

  • K251889myAirResmed Corp · 2026
  • K252078BreathePal Bilevel (GFM50-MD2201)Compal Electronics, Inc. · 2026
  • K251661Mariana Minerva; Mariana NimbusResmed Pty, Ltd. · 2026
  • K240778Vivo 1, Vivo 2Breas Medical AB · 2024
  • K231064ReddyPort ElbowSmd Manufacturing, LLC · 2023

https://510kreport.com/device/K031896 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031896: Nasal-Air Critical Care.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031896

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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