510(k) Report

510(k) · Cleared

Cleared

Volume Ventilator Circuit-Nebulizer

K833196510(k) TraditionalCleared Nov 3, 198345-day reviewClass I21 CFR 868.5240

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

Airlife, Inc. · CAI Circuit, Breathing (W Connector, Adaptor, Y Piece)

Cleared on Nov 3, 1983 after a 45-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Nov 3, 1983
Review
45 days
Class
Class I
Product code
CAI
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K833196Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All CAI devices

CAI Circuit, Breathing (W Connector, Adaptor, Y Piece): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CAI

FDA has decided no CAI device since 2007.

Median 510(k) review, days · CAI

Too few CAI 510(k)s in any year since 2007 to give a median.

Recalls per year · CAI

2in 2025

2008: 1422009: 12011: 12013: 12019: 12022: 12024: 12025: 2, 1 Class I2026 (partial year): 8, 3 Class I
2007high 142 (2008) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · CAI

108in 2025

2007: 122008: 292009: 152010: 732011: 1332012: 1252013: 942014: 622015: 322016: 1642017: 1542018: 392019: 622020: 712021: 1382022: 2442023: 2512024: 1172025: 108
2007high 251 (2023) · low 12 (2007)2025

MAUDE reports naming product code CAI, 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
20070—012
20080—14229
20090—115
20100—073
20110—1133
20120—0125
20130—194
20140—062
20150—032
20160—0164
20170—0154
20180—039
20190—162
20200—071
20210—0138
20220—1244
20230—0251
20240—1117
20250—2 (1)108
20260—8 (3)—

More from Airlife, Inc.

76 FDA decisions under this applicant name. See the company

  • K834570Volume Ventilator Circuit W/Water TrapAirlife, Inc. · 1984
  • K834573Aqua TrapAirlife, Inc. · 1984
  • K834077Single Use Nebulizer-Adjust-Air EntrainAirlife, Inc. · 1983
  • K833197Trach Swive/ConnectorAirlife, Inc. · 1983
  • K832725Dual Dial Venturi Style MaskAirlife, Inc. · 1983

Recent decisions in CAI

The CAI category page

  • K954480Condensate Collection KitNova-Ventrx · 1995
  • K953787Unicor, Inc. Adult Anesthesia Breathing CircuitUnicor, Inc. · 1995
  • K953788Unicor, Inc. Gas Sampling Lines & ConnectorsUnicor, Inc. · 1995
  • K952017Prima Mapleson D CircuitPrima, Inc. · 1995
  • K952014Prima Adult Temperature Monitoring Anesthesia CircuitsPrima, Inc. · 1995

https://510kreport.com/device/K833196 · printed Nov 4, 2026

Cite this page

510(k) Report. “K833196: Volume Ventilator Circuit-Nebulizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K833196

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026