Cleared Traditional

K121969 - U-RIGHT COMPRESSOR NEBULIZER

K121969 is an FDA 510(k) clearance for U-RIGHT COMPRESSOR NEBULIZER, manufactured by Taidoc Technology Corporation. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K121969 · Taidoc Technology Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
238d
Days
Class 2
Risk

K121969 is an FDA 510(k) clearance for the U-RIGHT COMPRESSOR NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Taidoc Technology Corporation (New Taipei City, TW). The FDA issued a Cleared decision on February 28, 2013 after a review of 238 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.

FDA 510(k) Submission Details - K121969

510(k) Number K121969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2012
Decision Date February 28, 2013
Days to Decision 238 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 140d · This submission: 238d
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 441
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K121969.
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · K-Jump Health Co., Ltd. · Mar 2013
PULMOSAL
K130091 · Pharmacaribe · Mar 2013
SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)
K123614 · Trudell Medical Intl. · Mar 2013
HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
K122857 · Pegasus Research Corp. · Nov 2012
ULTRASONIC NEBULIZER
K121154 · Foshan Gaunying Electronics Co., Ltd. · Aug 2012
SPIRALE DRUG DELIVERY SYSTEM
K111246 · Armstrong Medical , Ltd. · Aug 2012