Cleared Traditional

K832898 - NEBULIZER ACCESSORY FOR SERVO VENTILL

K832898 is an FDA 510(k) clearance for NEBULIZER ACCESSORY FOR SERVO VENTILL, manufactured by Siemens Elema AB. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K832898 · Siemens Elema AB · Anesthesiology device
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Nov 1983
Decision
91d
Days
Class 2
Risk

K832898 is an FDA 510(k) clearance for the NEBULIZER ACCESSORY FOR SERVO VENTILL. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Siemens Elema AB (Mchenry, US). The FDA issued a Cleared decision on November 25, 1983 after a review of 91 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Elema AB devices

FDA 510(k) Submission Details - K832898

510(k) Number K832898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1983
Decision Date November 25, 1983
Days to Decision 91 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
49d faster than avg
Panel avg: 140d · This submission: 91d
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 179
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K832898.
NEBULAIRE (IRC 1040) NEBULIZER PUMP
K851436 · Invacare Corp. · Jul 1985
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN
K834077 · Airlife, Inc. · Dec 1983
DISPOS. MEDICATION NEBULIZER
K831270 · Hospitak, Inc. · Jun 1983
SINGLE USE NEBULIZER, ADJUST. AIR-
K830895 · Airlife, Inc. · Apr 1983
AIRLIFE NEBULIZER HEATER
K821129 · Airlife, Inc. · May 1982