Cleared Traditional

TRACH CARE MDI ADAPTER (K900273) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K900273 · Ballard Medical Products · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
222d
Days
Class 2
Risk

K900273 is an FDA 510(k) clearance for the TRACH CARE MDI ADAPTER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Ballard Medical Products (Midvale, US). The FDA issued a Cleared decision on August 29, 1990 after a review of 222 days - an extended review 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: 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 Ballard Medical Products devices

Submission Details

510(k) Number K900273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1990
Decision Date August 29, 1990
Days to Decision 222 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 140d · This submission: 222d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 72
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K900273.
CLEVER TD-7001NEBULIZER
K122060 · Taidoc Technology Corporation · Mar 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013
BAXTER NEBULIZER CAP MODEL 2D0868
K962161 · Baxter Healthcare Corp · Aug 1996
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · Baxter Healthcare Corp · Nov 1988
VARIABLE NEBULIZER HEATER
K851074 · Travenol Laboratories, S.A. · Jun 1985
0.45% SODIUM CHLORIDE SOL./RESP. THERAPY
K800294 · Abbott Laboratories · Mar 1980