Cleared Traditional

K943761 - NON-BREATHING VALVE

K943761 is an FDA 510(k) clearance for NON-BREATHING VALVE, manufactured by Rondex Products, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K943761 · Rondex Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
100d
Days
Class 2
Risk

K943761 is an FDA 510(k) clearance for the NON-BREATHING VALVE. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Rondex Products, Inc. (Rockford, US). The FDA issued a Cleared decision on November 10, 1994 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5870 - 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 - K943761

510(k) Number K943761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 02, 1994
Decision Date November 10, 1994
Days to Decision 100 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 140d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBP Device Classification - Class 2, Special Controls

Product Code CBP Valve, Non-rebreathing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5870
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 - CBP Valve, Non-rebreathing

All 102
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K943761.
CPR SHIELD
K942671 · Rondex Products, Inc. · Feb 1995
PPM III
K940712 · O-Two Systems Intl., Inc. · Nov 1994
COMPLETE CPR KIT
K941008 · Mtm Health Products , Ltd. · Nov 1994
4-O2 JR. (CPR MOUTH BARRIER)
K945177 · Eagle Health Supplies · Nov 1994
PROTECTAIDE CPR PROTECTION PACK NO. 22100
K942468 · Protectaide, Inc. · Oct 1994
PROTECTAIDE CPR PROTECTION PACK
K942469 · Protectaide, Inc. · Oct 1994
K943761 · NON-BREATHING VALVE
Download PDF FDA Summary Rondex Products, Inc.