Cleared Traditional

K841158 - NEBULO 28 NEBULIZER KIT

K841158 is an FDA 510(k) clearance for NEBULO 28 NEBULIZER KIT, manufactured by Inspiron Corp.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K841158 · Inspiron Corp. · Anesthesiology device
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Mar 1984
Decision
11d
Days
Class 2
Risk

K841158 is an FDA 510(k) clearance for the NEBULO 28 NEBULIZER KIT. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Inspiron Corp. (Mchenry, US). The FDA issued a Cleared decision on March 30, 1984 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Inspiron Corp. devices

FDA 510(k) Submission Details - K841158

510(k) Number K841158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1984
Decision Date March 30, 1984
Days to Decision 11 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 132
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K841158.
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
K843932 · Inspiron Corp. · Oct 1984
VH820 HUMIDIFIER
K842340 · Bear Medical Systems, Inc. · Jul 1984
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · Respiratory Care, Inc. · Jan 1984
AQUAPAK 020 HUMIDIFIER ADAPTER
K833974 · Respiratory Care, Inc. · Dec 1983
A QUAPAK
K811073 · Respiratory Care, Inc. · Apr 1981