510(k) Report

FDA product code · Anesthesiology

Ventilator, Continuous, Non-Life-Supporting

MNSClass II21 CFR 868.5895510(k) required47 decisions since 19964 recalls

47 FDA decisions since 1996. 510(k) reviews decided 2021–2025 took a median of 267 days (half between 179 and 350). 4 recalls name this code, 1 of them Class I. The most-cited predicate is K060105, named by 8 later devices.

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

FIG. A — Illustration, anesthesiology panel

Twenty years of MNS at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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)—
FIG. 1 — MNS by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in MNS? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Related product codes

Other codes under 21 CFR 868.5895.