Cleared Traditional

K893030 - CHILD SIZE - FILTER FLEX (TM) (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893030 · Life Design Systems, Inc. · General Hospital
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Sep 1989
Decision
147d
Days
Class 2
Risk

K893030 is an FDA 510(k) clearance for the CHILD SIZE - FILTER FLEX (TM). Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Life Design Systems, Inc. (Franklin, US). The FDA issued a Cleared decision on September 18, 1989 after a review of 147 days - within the typical 510(k) review window.

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 Design Systems, Inc. devices

Submission Details

510(k) Number K893030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1989
Decision Date September 18, 1989
Days to Decision 147 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d slower than avg
Panel avg: 128d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 200
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K893030.
Ambu® Virobac II® Exhalation Filter
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Besmed Bacterial Filter and HMEF
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K223258 · Intersurgical , Ltd. · Jun 2023
Filter and HME/Filter
K221472 · Ningbo Huakun Medical Equipment Co., Ltd. · Feb 2023