Cleared Traditional

K910239 - NEBU-SOL METERED DOSE DISPENSER (TM)

K910239 is an FDA 510(k) clearance for NEBU-SOL METERED DOSE DISPENSER (TM), manufactured by Dey Laboratories, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K910239 · Dey Laboratories, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
120d
Days
Class 1
Risk

K910239 is an FDA 510(k) clearance for the NEBU-SOL METERED DOSE DISPENSER (TM). Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Dey Laboratories, Inc. (Napa, US). The FDA issued a Cleared decision on May 22, 1991 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dey Laboratories, Inc. devices

FDA 510(k) Submission Details - K910239

510(k) Number K910239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1991
Decision Date May 22, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 65
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K910239.
DYNAREX SUCTION CATHETERS & KITS
K922843 · Dynarex Corp. · Jan 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
STERILE MUCOUS SPECIMEN TRAP, DISPOSABLE
K923098 · Trinity Laboratories, Inc. · Sep 1992
MUCAID WITH SUCTION CATHETER AND EXTENSION TUBING
K910908 · Vygon Corp. · May 1991
MUCAID
K910909 · Vygon Corp. · May 1991
STERI-CATH-DL
K902687 · Concord/Portex · Aug 1990