Cleared Traditional

ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML (K990308) - FDA 510(k) Clearance

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

K990308 · Rocap Div. of Sabratek Corp. · General Hospital
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Dec 1999
Decision
312d
Days
Class 2
Risk

K990308 is an FDA 510(k) clearance for the ROCAP HEPARIN IV FLUSH SYRINGE, 100U/ML. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Rocap Div. of Sabratek Corp. (Orlando, US). The FDA issued a Cleared decision on December 10, 1999 after a review of 312 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Rocap Div. of Sabratek Corp. devices

Submission Details

510(k) Number K990308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1999
Decision Date December 10, 1999
Days to Decision 312 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
183d slower than avg
Panel avg: 129d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 116
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K990308.
HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML
K003245 · Baxter Healthcare Corp · Dec 2000
MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE
K001616 · Abbott Laboratories · Jul 2000
VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING
K992532 · Baxter Healthcare Corp · Jun 2000
0.9% SODIUM CHLORIDE FLUSH SYRINGE
K984590 · Baxter Healthcare Corp · Oct 1999
URETHANE PICC LINE MODEL UPICS-
K992198 · Cook, Inc. · Aug 1999
ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER
K984059 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1999