Cleared Special

K102658 - MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS

K102658 is an FDA 510(k) clearance for MINISPACER DUAL-SPRAY MDI ADAPTER WITH ..., manufactured by Thayer Medical Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 86-day FDA review.

K102658 · Thayer Medical Corp. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
86d
Days
Class 2
Risk

K102658 is an FDA 510(k) clearance for the MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECT.... Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Thayer Medical Corp. (Tucson, US). The FDA issued a Cleared decision on December 10, 2010 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102658

510(k) Number K102658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date December 10, 2010
Days to Decision 86 days
Submission Type Special
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
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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
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