Cleared Traditional

K121770 - HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER

K121770 is an FDA 510(k) clearance for HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER, manufactured by Headstar Medical Products Co., Ltd.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 306-day FDA review.

K121770 · Headstar Medical Products Co., Ltd. · Anesthesiology device
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Apr 2013
Decision
306d
Days
Class 2
Risk

K121770 is an FDA 510(k) clearance for the HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Headstar Medical Products Co., Ltd. (City, Taipei County, TW). The FDA issued a Cleared decision on April 17, 2013 after a review of 306 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Headstar Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K121770

510(k) Number K121770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2012
Decision Date April 17, 2013
Days to Decision 306 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 140d · This submission: 306d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K121770.
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K141214 · Teleflexmedical, Inc. · Dec 2014
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CLEVER TD-7001NEBULIZER
K122060 · Taidoc Technology Corporation · Mar 2013
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · K-Jump Health Co., Ltd. · Mar 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013