Cleared Traditional

K990310 - CHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)

K990310 is an FDA 510(k) clearance for CHARTER MEDICAL, manufactured by Charter Medical, Ltd.. The device is a Class 2 General Hospital device with product code CAK cleared through the Traditional 510(k) pathway after a 210-day FDA review.

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

FDA 510(k) Submission Details - K990310

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
Combination Product No
PCCP Authorized No
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.

CAK Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (CAK) and FDA review panel - the closest regulatory comparables to K990310.
HAEMONETICS 40U RBC FILTER BAG
K061103 · Haemonetics Corp. · May 2006
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
ALPHA MICRON 20/40 MICROAGGREGATE FILTER
K970225 · Alpha Therapeutic Corp. · Feb 1997
PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)
K960993 · Pall Biomedical Products Co. · Apr 1996
ALPHA MICRON 20 MICROAGGREGATE FILTER
K955515 · Alpha Therapeutic Corp. · Feb 1996