Cleared Special

K072670 - MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER

K072670 is an FDA 510(k) clearance for MODIFICATION TO: EFLOW ELECTRONIC INHAL..., manufactured by Pari Innovative Manufacturers, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Special 510(k) pathway after a 83-day FDA review.

K072670 · Pari Innovative Manufacturers, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2007
Decision
83d
Days
Class 2
Risk

K072670 is an FDA 510(k) clearance for the MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pari Innovative Manufacturers, Inc. (Midlothian, US). The FDA issued a Cleared decision on December 13, 2007 after a review of 83 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 - K072670

510(k) Number K072670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2007
Decision Date December 13, 2007
Days to Decision 83 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 140d · This submission: 83d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

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 Consultant

Intertek Testing Services
JAY KOGOMA

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 441
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