Cleared Traditional

K061381 - LC STAR WITH NASAL ADAPTER

K061381 is an FDA 510(k) clearance for LC STAR WITH NASAL ADAPTER, 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 15-day FDA review.

K061381 · Pari Innovative Manufacturers, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
15d
Days
Class 2
Risk

K061381 is an FDA 510(k) clearance for the LC STAR WITH NASAL ADAPTER. 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 June 2, 2006 after a review of 15 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 - K061381

510(k) Number K061381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2006
Decision Date June 02, 2006
Days to Decision 15 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
125d faster than avg
Panel avg: 140d · This submission: 15d
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

Citech
ROBERT MOSENKIS

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
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K061381.
BABYAIR
K060497 · Promedic, Inc. · Jul 2006
AG-PLUS, MODEL 91210
K060404 · Medel S.P.A. · Jun 2006
REVJET TURBO
K060842 · Promedic, Inc. · Jun 2006
OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30
K060811 · Omron Healthcare, Inc. · May 2006
TREK S NEBULIZER COMPRESSOR
K060357 · Pari Innovative Manufacturers, Inc. · Apr 2006
AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C
K053360 · Aerovectrx Corporation · Mar 2006
K061381 · LC STAR WITH NASAL ADAPTER
Download PDF FDA Summary Pari Innovative Manuf…