Cleared Traditional

K843797 - STERILE SALINE SOLUTION

K843797 is the FDA 510(k) clearance for STERILE SALINE SOLUTION by Paco Pharmaceutical Services, Inc.. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K843797 · Paco Pharmaceutical Services, Inc. · Anesthesiology device
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Jan 1985
Decision
113d
Days
Class 1
Risk

K843797 is an FDA 510(k) clearance for the STERILE SALINE SOLUTION. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Paco Pharmaceutical Services, Inc. (Lakewood, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 113 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 Paco Pharmaceutical Services, Inc. devices

Submission Details

510(k) Number K843797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1984
Decision Date January 18, 1985
Days to Decision 113 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 140d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 15
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K843797.
ARGYLE ASPIR-FLEX SUCTION CATHETER
K925556 · Sherwood Medical Co. · Jul 1993
ARGYLE AERO-JET SUCTION CATHETER
K922148 · Sherwood Medical Co. · Dec 1992
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983
RADIATION STERILIZED SUCTION CATHETERS
K820109 · Travenol Laboratories, S.A. · Jan 1982