Cleared Traditional

K953230 - CPR SUPER POCKET PACK

K953230 is the FDA 510(k) clearance for CPR SUPER POCKET PACK by Formosa-Cj Health Business Corp.. It is a Class 2 Anesthesiology device (product code CBP) cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K953230 · Formosa-Cj Health Business Corp. · Anesthesiology device
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Feb 1996
Decision
219d
Days
Class 2
Risk

K953230 is an FDA 510(k) clearance for the CPR SUPER POCKET PACK. Classified as Valve, Non-rebreathing (product code CBP), Class II - Special Controls.

Submitted by Formosa-Cj Health Business Corp. (Mccordsville, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 219 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.

View all Formosa-Cj Health Business Corp. devices

Submission Details

510(k) Number K953230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date February 14, 1996
Days to Decision 219 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 140d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 8
Devices cleared under the same product code (CBP) and FDA review panel - the closest regulatory comparables to K953230.
Altech® Exhalation Valve (Single Limb and Dual Limb)
K210992 · Meditera Tibbi Malzeme San VE Tic AS · Dec 2021
CPR Face Shield
K192285 · Firstar Healthcare Company Limited (Guangzhou) · Nov 2020
OJR215 Pressure Relief Manifold
K173770 · Fisher & Paykel Healthcare Limited · Apr 2019
RESCUE VALVE
K833748 · Respironics, Inc. · Dec 1983
WHISTLER IN-LINE PRESSURE RELEASE VALVE
K831246 · Airlife, Inc. · Jul 1983
ONE-WAY VALVE
K790151 · Airlife, Inc. · Mar 1979