Cleared Traditional

K933412 - SALINE SOLUTION-STERILE

K933412 is an FDA 510(k) clearance for SALINE SOLUTION-STERILE, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 Anesthesiology device with product code JOH cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K933412 · Trinity Laboratories, Inc. · Anesthesiology device
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Oct 1993
Decision
80d
Days
Class 2
Risk

K933412 is an FDA 510(k) clearance for the SALINE SOLUTION-STERILE. Classified as Tube Tracheostomy And Tube Cuff (product code JOH), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on October 1, 1993 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5800 - 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 - K933412

510(k) Number K933412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1993
Decision Date October 01, 1993
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOH Device Classification - Class 2, Special Controls

Product Code JOH Tube Tracheostomy And Tube Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5800
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 - JOH Tube Tracheostomy And Tube Cuff

All 70
Devices cleared under the same product code (JOH) and FDA review panel - the closest regulatory comparables to K933412.
EUROMEDICAL POLY TRACHEOTOMY TUBE
K945874 · Regulatory & Marketing Services, Inc. · Dec 1994
BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBES
K944178 · Bivona Medical Technologies · Oct 1994
PERCUTANEOUS TRACHEOSTOMY KIT
K936133 · Smiths Industries Medical Systems, Inc. · Mar 1994
TRACHEOSTOMY CARE TRAY
K923156 · Orion Life Systems, Inc. · Aug 1993
TRACHEOSTOMY CARE KIT (STERILE)
K925020 · Customed, Inc. · Jul 1993
TRACHEOSTOMY CARE KIT
K924243 · Transidyne General Corp. · Jun 1993