Cleared Traditional

K070498 - HYPER SAL

K070498 is an FDA 510(k) clearance for HYPER SAL, 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 65-day FDA review.

K070498 · Pari Innovative Manufacturers, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
65d
Days
Class 2
Risk

K070498 is an FDA 510(k) clearance for the HYPER SAL. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Pari Innovative Manufacturers, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on April 26, 2007 after a review of 65 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 - K070498

510(k) Number K070498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date April 26, 2007
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
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 499
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K070498.
FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS
K062484 · Flaem Nuova S.P.A. · Jun 2007
APEX MEDICAL MOBINEB, 9R-027 SERIES
K070990 · Apex Medical Corp. · May 2007
AERONEB PROFESSIONAL NEBULIZER SYSTEM
K070642 · Aerogen (Ireland), Ltd. · May 2007
HSINER NEBULIZER BOTTLE
K070948 · Hsiner · Apr 2007
FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB
K062014 · Flaem Nuova S.P.A. · Mar 2007
DELUXE NEBULIZER
K063449 · Access Point Medical, LLC · Mar 2007
K070498 · HYPER SAL
Download PDF FDA Summary Pari Innovative Manuf…