Cleared Traditional

K972728 - STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)

K972728 is an FDA 510(k) clearance for STERILE WATER FOR INJECTION PREFILLED S..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K972728

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.

FMF Device Classification - Class 2, Special Controls

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 523
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K972728.
PENETREASE
K980078 · P.T. Panca Pusaka Deli · Oct 1998
HUMAPEN AND HUMAPEN ERGO
K982842 · Eli Lilly and Co. · Sep 1998
LIGHT SABER ASPIRATION NEEDLE
K982018 · Minrad, Inc. · Aug 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998
MINRAD DRTS LIGHT SABER SYRINGE
K981140 · Minrad, Inc. · Jun 1998
B-D PEN ULTRA
K981797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998