Cleared Traditional

K062158 - LC SPRINT STAR

K062158 is an FDA 510(k) clearance for LC SPRINT STAR, manufactured by Pari Innovative Manufacturers, Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K062158 · Pari Innovative Manufacturers, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
31d
Days
Class 2
Risk

K062158 is an FDA 510(k) clearance for the LC SPRINT STAR. 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 August 28, 2006 after a review of 31 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K062158

510(k) Number K062158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2006
Decision Date August 28, 2006
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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
NEIL E DEVINE

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 499
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K060404 · Medel S.P.A. · Jun 2006
K062158 · LC SPRINT STAR
Download PDF FDA Summary Pari Innovative Manuf…