Cleared Traditional

K761300 - NEBULIZER CONTROL UNIT

K761300 is an FDA 510(k) clearance for NEBULIZER CONTROL UNIT, manufactured by Mcgaw Respiratory Therapy. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K761300 · Mcgaw Respiratory Therapy · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1976
Decision
9d
Days
Class 2
Risk

K761300 is an FDA 510(k) clearance for the NEBULIZER CONTROL UNIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Mcgaw Respiratory Therapy (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976 after a review of 9 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 Mcgaw Respiratory Therapy devices

FDA 510(k) Submission Details - K761300

510(k) Number K761300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1976
Decision Date December 30, 1976
Days to Decision 9 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
131d faster than avg
Panel avg: 140d · This submission: 9d
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 408
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K761300.
NEBULIZER, MOLEL 503, PART #17068
K771105 · Hospal Medical Corp. · Jul 1977
BRACKET BE 122-1
K770633 · Instrumentation Industries, Inc. · May 1977
NEBULIZER HEATER
K770828 · Ohio Medical Products · May 1977
ADDI-MIST
K760964 · Respiratory Care, Inc. · Dec 1976
U-MID PREFILLED NEBULIZER
K760585 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1976
NEBULIZER, HANDHELD (T UP-DRAFT)
K760489 · Hudson Oxygen Therapy Sales Co. · Sep 1976