Cleared Traditional

K790982 - INSPIRON NEBULO TM 28 NEBULIZER KIT

K790982 is an FDA 510(k) clearance for INSPIRON NEBULO TM 28 NEBULIZER KIT, manufactured by C.R. Bard, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K790982 · C.R. Bard, Inc. · Anesthesiology device
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Jun 1979
Decision
35d
Days
Class 2
Risk

K790982 is an FDA 510(k) clearance for the INSPIRON NEBULO TM 28 NEBULIZER KIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1979 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K790982

510(k) Number K790982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1979
Decision Date June 27, 1979
Days to Decision 35 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
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAF Device Classification - Class 2, Special Controls

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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 - CAF Nebulizer (direct Patient Interface)

All 198
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K790982.
INHALATION OPERATED NEBULIZER CODE
K791218 · Travenol Laboratories, S.A. · Jul 1979
MISTY NEBULIZER
K790892 · Airlife, Inc. · Jul 1979
SHERWOOD NEBULIZER KIT
K791089 · Sherwood Medical Co. · Jul 1979
I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL
K791042 · Airlife, Inc. · Jun 1979
NEBULIZER NO. M-175
K790924 · Mem Medical, Inc. · May 1979
NEBULIZER WITH 4-WAY T NO M-174
K790925 · Mem Medical, Inc. · May 1979