Cleared Traditional

K991355 - METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE (FDA 510(k) Clearance)

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

K991355 · Instrumentation Industries, Inc. · Anesthesiology device
Jan 2000
Decision
283d
Days
Class 2
Risk

K991355 is an FDA 510(k) clearance for the METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Instrumentation Industries, Inc. (Bethel Park, US). The FDA issued a Cleared decision on January 27, 2000 after a review of 283 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.

Submission Details

510(k) Number K991355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1999
Decision Date January 27, 2000
Days to Decision 283 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 225d · This submission: 283d
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 10
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K991355.
eRapid with eTrack System
K251572 · Pari Respiratory Equipment, Inc. · Dec 2025
Mesh Nebulizer (H6)
K251659 · Qingdao Future Medical Technology Co., Ltd. · Nov 2025
Portable mesh nebulizer (JM821)
K244035 · Shenzhen Jermei Medical Device Technology Co., Ltd. · Sep 2025
Compressor Nebulizer (NB-1100)
K243468 · Joytech Healthcare Co. , Ltd. · Jul 2025
HeroTracker Sense
K250022 · Voluntis · Jun 2025
AdheResp Smart Breath-actuated Mesh Nebulizer
K250583 · Hcmed Innovations Co., Ltd. · Jun 2025