Cleared Traditional

K914195 - RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED

K914195 is an FDA 510(k) clearance for RONDEX CPR NON REBREATHING VALVE #9030, 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 64-day FDA review.

K914195 · Rondex Products, Inc. · Anesthesiology device
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Nov 1991
Decision
64d
Days
Class 2
Risk

K914195 is an FDA 510(k) clearance for the RONDEX CPR NON REBREATHING VALVE #9030, MODIFIED. 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 8, 1991 after a review of 64 days - a notably fast clearance cycle.

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: 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 Rondex Products, Inc. devices

FDA 510(k) Submission Details - K914195

510(k) Number K914195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date November 08, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 140d · This submission: 64d
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 62
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K914195.
CPR MICROMASK
K943386 · Plasco, Inc. · Feb 1995
K.P.R. (KING PERSONAL RESUSCITATOR)
K943402 · King Systems Corp. · Aug 1994
CPROTECTOR
K934821 · Certified Safety Mfg., Inc. · Jan 1994
LSP DEMAND INHALATOR VALVE MODEL SPOO68 W/MASK
K884543 · Sechrist Industries, Inc. · Dec 1988
NON-REBREATHING TEE PIECE (NRTP)
K883988 · Dhd Medical Products Div. Diemolding Corp. · Oct 1988
LIFECARE EXHALATION VALVE #06-699
K873570 · Lifecare Services, Inc. · Nov 1987