Product code MNS— Anesthesiology
VPAP TX
- Classification name
- Ventilator, Continuous, Non-Life-Supporting
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Total cleared
- 47
- First cleared
- Most recent
Market context for product code MNS
FDA has cleared devices under product code MNS between 1996 and 2026, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2024
- 2023
- 2022
- 2018
- 2017
- 2016
- 2013
- 2012
- 2011
- 2010
- 2009
- 2007
- 2006
- 2005
Top applicants under product code MNS
Adverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code MNS
- K251889 — myAir
- K252078 — BreathePal Bilevel (GFM50-MD2201)
- K251661 — Mariana Minerva; Mariana Nimbus
- K240778 — Vivo 1, Vivo 2
- K231064 — ReddyPort Elbow
- K213169 — BPAP System
- K171827 — ReddyPort NIV Access Elbow
- K161492 — Juno VPAP ST-A
- K161487 — VPAP Adapt SV, VPAP Tx, S9 VPAP Tx
- K153061 — Juno VPAP ST-A
- K132371 — EASYCARE ONLINE
- K123511 — S9 VPAP TX
- K123557 — EASYCARE ONLINE
- K122324 — VPAP S-A
- K113714 — VPAP TX
- K113288 — VPAP ST-A
- K113815 — RESSCAN
- K113053 — BIPAP A 30 VENTILATORY SUPPORT SYSTEM
- K112914 — VPAP TX
- K111378 — OXIMETRY INTERFACE KIT
- K102465 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K101130 — BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK
- K093731 — VPAP III ST-A
- K093070 — DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES
- K092818 — BIPAP AVAPS VENTILATORY SUPPORT SYSTEM
- K092186 — VPAP TX
- K090539 — BIPAP AUTOSV ADVANCED
- K092043 — BIPAP SYNCHRONY 2
- K090248 — BIPAP AUTOSV
- K071509 — BIPAP SYNCHRONY 2 VENTILATORY SUPPORT SYSTEM
- K070328 — BIPAP SYNCHRONY WITH AVAPS
- K063540 — BIPAP AUTOSV
- K063533 — BIPAP SYNCHRONY
- K060546 — BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 30
- K060105 — VPAP III ST-A/KIDSTA MASK SYSTEM
- K053168 — BIPAP FOCUS
- K051364 — VPAP ADAPT
- K033276 — VPAP III ST-A
- K031896 — NASAL-AIR CRITICAL CARE
- K031656 — BIPAP HARMONY VENTILATORY SUPPORT SYSTEM
- K020777 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX
- K012323 — BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM
- K992530 — BIPAP SYNCHRONY HC
- K984407 — BIPAP HARMONY S/T, MODEL 1001445
- K974417 — SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
- K962517 — MODEL 7700 QUANTUM PRESSURE SUPPORT VENTILATOR PSV
- K942210 — PURITAN-BENNETT 335 RESPIRATORY SUPPORT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.