Cleared Traditional

K772348 - NEBULIZER ADAPTER

K772348 is an FDA 510(k) clearance for NEBULIZER ADAPTER, manufactured by Respiratory Care, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K772348 · Respiratory Care, Inc. · Anesthesiology device
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Jan 1978
Decision
11d
Days
Class 2
Risk

K772348 is an FDA 510(k) clearance for the NEBULIZER ADAPTER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respiratory Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 3, 1978 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K772348

510(k) Number K772348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1977
Decision Date January 03, 1978
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.

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 245
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K772348.
INSPIRON MANIFOLD (DOUBLE)
K772294 · C.R. Bard, Inc. · Jan 1978
INSPIRON MANIFOLD (SINGLE)
K772295 · C.R. Bard, Inc. · Jan 1978
INSPIRON MANIFOLD
K772296 · C.R. Bard, Inc. · Jan 1978
NEBULIZER SET-2C7105
K772222 · Travenol Laboratories, S.A. · Dec 1977
MANIFOLD & NEBULIZER, UNIVERSAL
K772068 · Inspiron Corp. · Nov 1977
VENTILATOR SETUP, VOLUME
K772070 · Inspiron Corp. · Nov 1977