Cleared Traditional

K982558 - BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE

K982558 is an FDA 510(k) clearance for BD PREEFILE NORMAL SALINE FLUSH SYRINGE..., manufactured by Bd/Preefil. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 595-day FDA review.

K982558 · Bd/Preefil · General Hospital
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Mar 2000
Decision
595d
Days
Class 2
Risk

K982558 is an FDA 510(k) clearance for the BD PREEFILE NORMAL SALINE FLUSH SYRINGE FLUSH SYRINGE. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Bd/Preefil (Franklin Lakes, US). The FDA issued a Cleared decision on March 8, 2000 after a review of 595 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Bd/Preefil devices

FDA 510(k) Submission Details - K982558

510(k) Number K982558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1998
Decision Date March 08, 2000
Days to Decision 595 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
466d slower than avg
Panel avg: 129d · This submission: 595d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 352
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K982558.
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532 · Baxter Healthcare Corp · Jun 2000
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K000235 · Becton Dickinson Infusion Therapy Systems, Inc. · Apr 2000
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K000087 · The Kendal Co. · Mar 2000
ARROWG +ARD BLUE PLUS ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K993691 · Arrow Intl., Inc. · Mar 2000
ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML
K990308 · Rocap Div. of Sabratek Corp. · Dec 1999
HEPARIN IV FLUSH SYRINGE, 10 U/ML \
K990390 · Rocap Div. of Sabratek Corp. · Dec 1999