Cleared Traditional

K000685 - CHARTER MEDICAL NEONATAL SYRINGE SET

K000685 is an FDA 510(k) clearance for CHARTER MEDICAL NEONATAL SYRINGE SET, manufactured by Charter Medical, Ltd.. The device is a Class 2 General Hospital device with product code BRZ cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K000685 · Charter Medical, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
168d
Days
Class 2
Risk

K000685 is an FDA 510(k) clearance for the CHARTER MEDICAL NEONATAL SYRINGE SET. Classified as Set, Blood Transfusion (product code BRZ), Class II - Special Controls.

Submitted by Charter Medical, Ltd. (Lakewood, US). The FDA issued a Cleared decision on August 15, 2000 after a review of 168 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 - K000685

510(k) Number K000685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2000
Decision Date August 15, 2000
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BRZ Device Classification - Class 2, Special Controls

Product Code BRZ Set, 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 - BRZ Set, Blood Transfusion

All 15
Devices cleared under the same product code (BRZ) and FDA review panel - the closest regulatory comparables to K000685.
PENTATRASFU BLOOD TRANSFUSION SETS
K041496 · Pentaferte S.P.A · Jun 2005
30 ML OR 60 ML PEDI-SYRINGE FILTER
K050805 · Blood Products Specialties, LLC · Jun 2005
BLOOD HAND PUMP ADMINISTRATION SET
K050115 · Cardinal Health, Alaris Products · Apr 2005
MODIFIED BLOOD RECIPIENT SET
K993120 · Baxter Healthcare Corp · Nov 1999
PROTOS BLOOD TRANSFUSION SET
K972843 · Globe Ent., Inc. · Dec 1997
Y-TYPE BLOOD ADMINISTRATION SET
K940074 · Puritas Health Care, Inc. · Apr 1994