Cleared Traditional

K925388 - LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER

K925388 is an FDA 510(k) clearance for LIFE SHIELD HEALTHCARE PRODUCTS BREATHI..., manufactured by Life Shield Healthcare Products, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K925388 · Life Shield Healthcare Products, Inc. · General Hospital
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May 1993
Decision
197d
Days
Class 2
Risk

K925388 is an FDA 510(k) clearance for the LIFE SHIELD HEALTHCARE PRODUCTS BREATHING FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Life Shield Healthcare Products, Inc. (Noblesville, US). The FDA issued a Cleared decision on May 11, 1993 after a review of 197 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Shield Healthcare Products, Inc. devices

FDA 510(k) Submission Details - K925388

510(k) Number K925388 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1992
Decision Date May 11, 1993
Days to Decision 197 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 129d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 General Hospital devices follow this clearance model.

Regulatory Peers - CAH Filter, Bacterial, Breathing-circuit

All 108
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K925388.
HEPA FILTERED HME
K930816 · Intertech Resources, Inc. · Jul 1993
BREATHING FILTERS 1942T/1941T/2014T
K925462 · Intersurgical, Inc. · May 1993
BREATHING FILTER
K931842 · Mag, Inc. · May 1993
MED-PLASTICS INTL., INC. BREATHING FILTER
K930760 · Med-Plastics Intl., Inc. · Mar 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
K925217 · Merit Medical Systems, Inc. · Jan 1993
VENTILATOR CIRCUITS
K920885 · Vital Signs, Inc. · Oct 1992