Cleared Traditional

K896923 - INTERTECH/INSPIRON MEDICATION NEBULIZER KIT

K896923 is an FDA 510(k) clearance for INTERTECH/INSPIRON MEDICATION NEBULIZER KIT, manufactured by Intertech Resources, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K896923 · Intertech Resources, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1990
Decision
90d
Days
Class 2
Risk

K896923 is an FDA 510(k) clearance for the INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on March 12, 1990 after a review of 90 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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K896923

510(k) Number K896923 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 12, 1989
Decision Date March 12, 1990
Days to Decision 90 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
50d faster than avg
Panel avg: 140d · This submission: 90d
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 175
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K896923.
WATER COLUMN RELIEF VALVE
K904398 · Icn Pharmaceuticals, Inc. · Jul 1991
MDI ADAPTOR
K900783 · Hudson Oxygen Therapy Sales Co. · Jul 1990
IN-THE NEBULIZER
K900470 · Hudson Oxygen Therapy Sales Co. · May 1990
(HEART) NEBULIZER
K896696 · Vortran Medical Technology 1, Inc. · Feb 1990
CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER
K895231 · Hudson Oxygen Therapy Sales Co. · Oct 1989
MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD
K894138 · Medipart Jerry Alexander · Sep 1989