Cleared Traditional

K941969 - ENDOPLUS

K941969 is an FDA 510(k) clearance for ENDOPLUS, manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 2 Anesthesiology device with product code BTR cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K941969 · Wembley Rubber Products (M) Sdn Bhd · Anesthesiology device
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Jun 1994
Decision
61d
Days
Class 2
Risk

K941969 is an FDA 510(k) clearance for the ENDOPLUS. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Sepang Selangor, MY). The FDA issued a Cleared decision on June 22, 1994 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K941969

510(k) Number K941969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date June 22, 1994
Days to Decision 61 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
79d faster than avg
Panel avg: 140d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTR Device Classification - Class 2, Special Controls

Product Code BTR Tube, Tracheal (w/wo Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5730
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 - BTR Tube, Tracheal (w/wo Connector)

All 147
Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K941969.
QUICK-LOCK
K945816 · B&B Medical Technologies, Inc. · Jan 1995
GENERAL ANESTHESIA SYSTEM
K945455 · Vital Signs, Inc. · Dec 1994
SURE-LOCK VENTILATOR TUBING HOLDER
K944324 · B&B Medical Technologies, Inc. · Nov 1994
RAE II TRACHEAL TUBE
K941246 · Mallinckrodt Medical · Apr 1994
DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINE
K934465 · Smiths Industries Medical Systems, Inc. · Jan 1994
BIVONA ILLUMINATED ENDOTRACHEAL TUBE
K933398 · Bivona Medical Technologies · Oct 1993