Cleared Traditional

K082541 - HEALTHLINE MEDICATOR / REDINEB AEROSOL ...

K082541 is an FDA 510(k) clearance for HEALTHLINE MEDICATOR / REDINEB AEROSOL ..., manufactured by Medi Nuclear Corp., Inc.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K082541 · Medi Nuclear Corp., Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
85d
Days
Class 2
Risk

K082541 is an FDA 510(k) clearance for the HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Medi Nuclear Corp., Inc. (Baldwin Park, US). The FDA issued a Cleared decision on November 26, 2008 after a review of 85 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.

View all Medi Nuclear Corp., Inc. devices

FDA 510(k) Submission Details - K082541

510(k) Number K082541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2008
Decision Date November 26, 2008
Days to Decision 85 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
55d faster than avg
Panel avg: 140d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 199
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K082541.
RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC
K091111 · Instrumentation Industries, Inc. · Dec 2009
ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210
K083256 · K-Jump Health Co., Ltd. · Jun 2009
VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
K090840 · Ventlab Corp. · Jun 2009
ULTRASONIC NEBULIZER SYSTEM, MODEL HL100
K081738 · Health & Life Co., Ltd. · Sep 2008
NEB-U-MASK SYSTEM, MODELS 1895, 1896
K080230 · Teleflexmedical, Inc. · Jun 2008
AMSURE NEBULIZER
K070411 · Amsino International, Inc. · Oct 2007