Cleared Traditional

K760845 - SOLO-SPHERE HEATER

K760845 is an FDA 510(k) clearance for SOLO-SPHERE HEATER, manufactured by Respiratory Therapy. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K760845 · Respiratory Therapy · Anesthesiology device
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Oct 1976
Decision
13d
Days
Class 2
Risk

K760845 is an FDA 510(k) clearance for the SOLO-SPHERE HEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respiratory Therapy (Mchenry, US). The FDA issued a Cleared decision on October 27, 1976 after a review of 13 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.

FDA 510(k) Submission Details - K760845

510(k) Number K760845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1976
Decision Date October 27, 1976
Days to Decision 13 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 140d · This submission: 13d
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 471
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K760845.
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
NEBULIZER, MICRO (ADDI-MIST)
K760335 · Respiratory Care, Inc. · Aug 1976
K760845 · SOLO-SPHERE HEATER
Download PDF Respiratory Therapy