Cleared Traditional

K950206 - FISONEB(R) II

K950206 is an FDA 510(k) clearance for FISONEB II, manufactured by Fisons Corp.. The device is a Class 2 Anesthesiology device with product code CAF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K950206 · Fisons Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
9d
Days
Class 2
Risk

K950206 is an FDA 510(k) clearance for the FISONEB(R) II. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Fisons Corp. (Rochester, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 9 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 Fisons Corp. devices

FDA 510(k) Submission Details - K950206

510(k) Number K950206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1995
Decision Date January 27, 1995
Days to Decision 9 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
131d faster than avg
Panel avg: 140d · This submission: 9d
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 407
Devices cleared under the same product code (CAF) and FDA review panel - the closest regulatory comparables to K950206.
AIRSEP NEWLIFE AIR OUTLET OPTION
K944020 · Airsep Corp. · Mar 1995
3002 AEROMAX
K942444 · Medical Industries America, Inc. · Mar 1995
4003 AEROLITE
K942208 · Medical Industries America, Inc. · Feb 1995
CAREPAK
K942350 · Precision Medical, Inc. · Dec 1994
UNIHEART
K943600 · Vortran Medical Technology 1, Inc. · Oct 1994
AUTONEB ACCESSORY CROSS (AAC)
K944643 · Vortran Medical Technology 1, Inc. · Oct 1994