Cleared Traditional

K844491 - MEDIPART FILTER & TUBING MP-02X

K844491 is an FDA 510(k) clearance for MEDIPART FILTER & TUBING MP-02X, 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 14-day FDA review.

K844491 · Medipart Jerry Alexander · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1984
Decision
14d
Days
Class 2
Risk

K844491 is an FDA 510(k) clearance for the MEDIPART FILTER & TUBING MP-02X. 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 December 4, 1984 after a review of 14 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 - K844491

510(k) Number K844491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1984
Decision Date December 04, 1984
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 K844491.
MEDIPART BACTERIA FILTER MP-2615
K853577 · Medipart Jerry Alexander · Oct 1985
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 BACTERIA FILTER MP-30X
K844492 · Medipart Jerry Alexander · Dec 1984
FILTER-FLEX
K841236 · Life Design Systems, Inc. · Apr 1984
PALL COALESCER
K840960 · Pall Biomedical Products Co. · Mar 1984