Cleared Traditional

K926280 - STANDARD NEBULIZER HEATER

K926280 is an FDA 510(k) clearance for STANDARD NEBULIZER HEATER, manufactured by Professional Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 463-day FDA review.

K926280 · Professional Medical Products, Inc. · Anesthesiology device
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Mar 1994
Decision
463d
Days
Class 2
Risk

K926280 is an FDA 510(k) clearance for the STANDARD NEBULIZER HEATER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Professional Medical Products, Inc. (Ashland, US). The FDA issued a Cleared decision on March 22, 1994 after a review of 463 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Professional Medical Products, Inc. devices

FDA 510(k) Submission Details - K926280

510(k) Number K926280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1992
Decision Date March 22, 1994
Days to Decision 463 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
323d slower than avg
Panel avg: 140d · This submission: 463d
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 402
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K926280.
UNIHEART
K943600 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB ACCESSORY CROSS (AAC)
K944643 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT
K935693 · Vortran Medical Technology 1, Inc. · Aug 1994
AEROCHAMBER W/MASK, MODIFIED
K930574 · Monaghan Medical Corp. · Jan 1994
VENTI-GENTLE-HALER(TM)
K933915 · Vortran Medical Technology 1, Inc. · Oct 1993
STERI-CATH MDI
K923559 · Concord/Portex · Oct 1993