Cleared Traditional

K101424 - PHARMACARIBE INHALED SALINE SOLUTIONS

K101424 is an FDA 510(k) clearance for PHARMACARIBE INHALED SALINE SOLUTIONS, manufactured by Pharmacaribe. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K101424 · Pharmacaribe · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
89d
Days
Class 2
Risk

K101424 is an FDA 510(k) clearance for the PHARMACARIBE INHALED SALINE SOLUTIONS. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pharmacaribe (Bonita Springs, US). The FDA issued a Cleared decision on August 17, 2010 after a review of 89 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 Pharmacaribe devices

FDA 510(k) Submission Details - K101424

510(k) Number K101424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2010
Decision Date August 17, 2010
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 224
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K101424.
ULTRASONIC NEBULIZER (MESH TYPE)
K121520 · K-Jump Health Co., Ltd. · Mar 2013
U-RIGHT COMPRESSOR NEBULIZER
K121969 · Taidoc Technology Corporation · Feb 2013
COMP A-I-R
K110860 · Omron Healthcare, Inc. · Sep 2011
RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V
K101857 · Instrumentation Industries, Inc. · Jul 2010
MERITS MODEL N SERIES NEBULIZER COMPRESSORS
K092859 · Merits Health Products Co., Ltd. · Jul 2010
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