Cleared Traditional

K831270 - DISPOS. MEDICATION NEBULIZER

K831270 is an FDA 510(k) clearance for DISPOS. MEDICATION NEBULIZER, manufactured by Hospitak, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K831270 · Hospitak, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
50d
Days
Class 2
Risk

K831270 is an FDA 510(k) clearance for the DISPOS. MEDICATION NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Hospitak, Inc. (Walker, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 50 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 Hospitak, Inc. devices

FDA 510(k) Submission Details - K831270

510(k) Number K831270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1983
Decision Date June 08, 1983
Days to Decision 50 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
90d faster than avg
Panel avg: 140d · This submission: 50d
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 190
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K831270.
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
NEBULIZER ACCESSORY FOR SERVO VENTILL
K832898 · Siemens Elema AB · Nov 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · Airlife, Inc. · Apr 1983
AIRLIFE NEBULIZER HEATER
K821129 · Airlife, Inc. · May 1982
MISTY NEBULIZER
K802477 · Airlife, Inc. · Oct 1980