Cleared Traditional

K922033 - SALINE SOLUTION- STERILE

K922033 is an FDA 510(k) clearance for SALINE SOLUTION- STERILE, manufactured by Trinity Laboratories, Inc.. The device is a Class 1 Anesthesiology device with product code CCQ cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K922033 · Trinity Laboratories, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
81d
Days
Class 1
Risk

K922033 is an FDA 510(k) clearance for the SALINE SOLUTION- STERILE. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - 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 Trinity Laboratories, Inc. devices

FDA 510(k) Submission Details - K922033

510(k) Number K922033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1992
Decision Date July 21, 1992
Days to Decision 81 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 140d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

CCQ Device Classification - Class 1, General Controls

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
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 - CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)

All 20
Devices cleared under the same product code (CCQ) and FDA review panel - the closest regulatory comparables to K922033.
MODIFIED AEROCHAMBER WITH MASK
K900576 · Monaghan Medical Corp. · May 1991
MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER
K900557 · Monaghan Medical Corp. · Apr 1991
PFEIFFER METERED DOSAGE SYSTEM
K896070 · Syva Co. · Jan 1990
FREEWAY NEBULIZER COMPRESSOR
K895592 · Lifecare Services, Inc. · Nov 1989
DEVILBISS MODEL 6610D
K894441 · Devilbiss Health Care, Inc. · Oct 1989
DEVILBISS MODEL 8500D AND 8500D-608
K894244 · Devilbiss Health Care, Inc. · Oct 1989