Cleared Traditional

K953414 - CPR MICROMASK WITH OXYGEN INLET

K953414 is an FDA 510(k) clearance for CPR MICROMASK WITH OXYGEN INLET, 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 244-day FDA review.

K953414 · Plasco, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
244d
Days
Class 2
Risk

K953414 is an FDA 510(k) clearance for the CPR MICROMASK WITH OXYGEN INLET. 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 20, 1996 after a review of 244 days - an extended review 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: 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 - K953414

510(k) Number K953414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1995
Decision Date March 20, 1996
Days to Decision 244 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
104d slower than avg
Panel avg: 140d · This submission: 244d
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 90
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K953414.
RESCUE BREATHER
K955520 · International Safety, Inc. · Oct 1996
CPR LIFE MASK COMPACT BARRIER
K954426 · Carefree Trading, Inc. · Sep 1996
MONTGOMERY TRACHEOSTOMY SPEAKING VALVE
K955634 · Boston Medical Products, Inc. · Jun 1996
SPIRACLE TECHNOLOTY GASEOUS OXYGEN SUPPLY VALVE
K953349 · Spiracle Technology · Feb 1996
CPR SUPER POCKET PACK
K953230 · Formosa-Cj Health Business Corp. · Feb 1996
CPR MASK & RELATED FAMILY KITS
K953461 · Safetec of America, Inc. · Jan 1996
K953414 · CPR MICROMASK WITH OXYGEN INLET
Download PDF FDA Summary Plasco, Inc.