Cleared Traditional

K772068 - MANIFOLD & NEBULIZER, UNIVERSAL

K772068 is an FDA 510(k) clearance for MANIFOLD & NEBULIZER, manufactured by Inspiron Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K772068 · Inspiron Corp. · Anesthesiology device
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Nov 1977
Decision
14d
Days
Class 2
Risk

K772068 is an FDA 510(k) clearance for the MANIFOLD & NEBULIZER, UNIVERSAL. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Inspiron Corp. (Walker, US). The FDA issued a Cleared decision on November 15, 1977 after a review of 14 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 Inspiron Corp. devices

FDA 510(k) Submission Details - K772068

510(k) Number K772068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1977
Decision Date November 15, 1977
Days to Decision 14 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
126d faster than avg
Panel avg: 140d · This submission: 14d
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 244
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K772068.
INSPIRON MANIFOLD
K772296 · C.R. Bard, Inc. · Jan 1978
NEBULIZER ADAPTER
K772348 · Respiratory Care, Inc. · Jan 1978
NEBULIZER SET-2C7105
K772222 · Travenol Laboratories, S.A. · Dec 1977
VENTILATOR SETUP, VOLUME
K772070 · Inspiron Corp. · Nov 1977
MANIFOLD & NEBU. FOR SINGLE LINE MACH.
K772071 · Inspiron Corp. · Nov 1977
MANIFOLD & NEBU. FOR DOUB. LINE MACH.
K772072 · Inspiron Corp. · Nov 1977