Cleared Traditional

K950769 - CPR MICROMASK PLUS CATALOG NO 73-402

K950769 is an FDA 510(k) clearance for CPR MICROMASK PLUS CATALOG NO 73-402, manufactured by Plasco, Inc.. The device is a Class 2 Anesthesiology device with product code CBP cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K950769 · Plasco, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
17d
Days
Class 2
Risk

K950769 is an FDA 510(k) clearance for the CPR MICROMASK PLUS CATALOG NO 73-402. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Plasco, Inc. (Gurnee, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 17 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 Plasco, Inc. devices

FDA 510(k) Submission Details - K950769

510(k) Number K950769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date March 10, 1995
Days to Decision 17 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
123d faster than avg
Panel avg: 140d · This submission: 17d
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 44
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K950769.
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
CPR MICROMASK WITH OXYGEN INLET
K953414 · Plasco, Inc. · Mar 1996
CPR MICROMASK
K951483 · Plasco, Inc. · Oct 1995
CPR MICROSHIELD II
K950770 · Plasco, Inc. · Mar 1995
CPR MICROMASK
K943386 · Plasco, Inc. · Feb 1995
K.P.R. (KING PERSONAL RESUSCITATOR)
K943402 · King Systems Corp. · Aug 1994