Cleared Traditional

K902383 - STERI-CATH(TM)

K902383 is an FDA 510(k) clearance for STERI-CATH(TM), manufactured by Concord/Portex. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K902383 · Concord/Portex · Anesthesiology device
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Jul 1990
Decision
43d
Days
Class 1
Risk

K902383 is an FDA 510(k) clearance for the STERI-CATH(TM). Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Concord/Portex (Keene, US). The FDA issued a Cleared decision on July 12, 1990 after a review of 43 days - a notably fast clearance cycle.

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: 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 Concord/Portex devices

FDA 510(k) Submission Details - K902383

510(k) Number K902383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date July 12, 1990
Days to Decision 43 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 140d · This submission: 43d
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 64
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K902383.
STERI-CATH-DL
K902687 · Concord/Portex · Aug 1990
BUSSE BAC/SHIELD
K902297 · Busse Hospital Disposables, Inc. · Aug 1990
SUCTION CATHETER, STERILE
K902814 · Orion Life Systems, Inc. · Aug 1990
TRACHAEL SUCTION SET
K896887 · Orion Life Systems, Inc. · Apr 1990
SUCTION CATHETER KIT
K896797 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
MUCOUS TRAP
K896560 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990