Cleared Traditional

K972728 - STERILE WATER FOR INJECTION PREFILLED S...

K972728 is the FDA 510(k) clearance for STERILE WATER FOR INJECTION PREFILLED S... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 359-day FDA review.

K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
359d
Days
Class 2
Risk

K972728 is an FDA 510(k) clearance for the STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS). Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 15, 1998 after a review of 359 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K972728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1997
Decision Date July 15, 1998
Days to Decision 359 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
230d slower than avg
Panel avg: 129d · This submission: 359d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 - FMF Syringe, Piston

All 311
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K972728.
TERUMO U-100 INSULIN SYRINGE
K992802 · Terumo Medical Corp. · Sep 1999
MTI 1 ML SYRINGE
K991225 · Micro Therapeutics, Inc. · Jul 1999
MONOJECT INSULIN SYRINGE
K991758 · The Kendal Co. · Jun 1999
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
BECTON DICKINSON SYRINGE
K980987 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998