Cleared Traditional

K894299 - REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM

K894299 is an FDA 510(k) clearance for REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM, manufactured by Repro-Med Systems, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K894299 · Repro-Med Systems, Inc. · Anesthesiology device
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Sep 1989
Decision
92d
Days
Class 1
Risk

K894299 is an FDA 510(k) clearance for the REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Repro-Med Systems, Inc. (Middletown, US). The FDA issued a Cleared decision on September 22, 1989 after a review of 92 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.

FDA 510(k) Submission Details - K894299

510(k) Number K894299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1989
Decision Date September 22, 1989
Days to Decision 92 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
48d faster than avg
Panel avg: 140d · This submission: 92d
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 83
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K894299.
SUCTION CATHETER KIT
K896797 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
MUCOUS TRAP
K896560 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
NO. 34100 - 8 FR & NO. 34400 - 14 FR CLOSED TRACH.
K896321 · Superior Healthcare Group, Inc. · Nov 1989
NU-TRAP SUCTION CATHETER W/MUCUS TRAP
K893462 · Atheus Corp. · Jun 1989
MUC-X
K893204 · Island Medical · Jun 1989
KENDALL CURITY SUCTION CATHETERS
K892441 · The Kendal Co. · May 1989
K894299 · REPRO-MED EMERGENCY AIRWAY VACUUM SYSTEM
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