Cleared Traditional

K853577 - MEDIPART BACTERIA FILTER MP-2615

K853577 is an FDA 510(k) clearance for MEDIPART BACTERIA FILTER MP-2615, manufactured by Medipart Jerry Alexander. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K853577 · Medipart Jerry Alexander · General Hospital
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Oct 1985
Decision
65d
Days
Class 2
Risk

K853577 is an FDA 510(k) clearance for the MEDIPART BACTERIA FILTER MP-2615. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Medipart Jerry Alexander (Cary, US). The FDA issued a Cleared decision on October 30, 1985 after a review of 65 days - a notably fast clearance 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: 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 Medipart Jerry Alexander devices

FDA 510(k) Submission Details - K853577

510(k) Number K853577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1985
Decision Date October 30, 1985
Days to Decision 65 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 129d · This submission: 65d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K853577.
MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER
K862787 · Medipart Jerry Alexander · Aug 1986
MP-01X DISPOSABLE BACTERIA FILTER KIT
K862789 · Medipart Jerry Alexander · Aug 1986
MP-01X-I DISPOSABLE FILTER KIT
K862790 · Medipart Jerry Alexander · Aug 1986
AMERICAN TWA WAY FILTER -BACTERIAL/VIRAL-RETENTIVE
K850265 · American Pharmaseal Div. Ahsc · Apr 1985
PALL GAS LINE GUARDIAN FILTER
K850327 · Pall Biomedical Products Co. · Feb 1985
MEDIPART FILTER & TUBING MP-02X
K844491 · Medipart Jerry Alexander · Dec 1984