Cleared Traditional

InnoSpire Go (K170853) - FDA 510(k) Clearance

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

K170853 · Respironics Respiratory Drug Delivery (Uk) , Ltd. · Anesthesiology device
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Nov 2017
Decision
225d
Days
Class 2
Risk

K170853 is an FDA 510(k) clearance for the InnoSpire Go. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Respironics Respiratory Drug Delivery (Uk) , Ltd. (Chichester, GB). The FDA issued a Cleared decision on November 2, 2017 after a review of 225 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 Respironics Respiratory Drug Delivery (Uk) , Ltd. devices

Submission Details

510(k) Number K170853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2017
Decision Date November 02, 2017
Days to Decision 225 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 140d · This submission: 225d
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 76
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