Cleared Traditional

CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER) (K990310) - FDA 510(k) Clearance

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

K990310 · Charter Medical, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
210d
Days
Class 2
Risk

K990310 is an FDA 510(k) clearance for the CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER). Classified as Microfilter, Blood Transfusion (product code CAK), Class II - Special Controls.

Submitted by Charter Medical, Ltd. (Lakewood, US). The FDA issued a Cleared decision on August 30, 1999 after a review of 210 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Charter Medical, Ltd. devices

Submission Details

510(k) Number K990310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date August 30, 1999
Days to Decision 210 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 129d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAK Microfilter, Blood Transfusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - CAK Microfilter, Blood Transfusion

All 35
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K990310.
FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72
K982822 · Baxter Healthcare Corp · Sep 1998
FENWAL 40 MICRON TRANSFUSION FILTER
K972159 · Baxter Healthcare Corp · Jul 1997
SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS
K904221 · Baxter Healthcare Corp · Oct 1990
SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS
K904223 · Baxter Healthcare Corp · Oct 1990
RESUBMITTED MICRON TRANSFUSION FILTER
K873873 · Travenol Laboratories, S.A. · Oct 1987
20 MICRON HIGH CAPACITY TRANS/FILTER
K830057 · Travenol Laboratories, S.A. · Jan 1983