Cleared Traditional

SAFETY SYRINGE (K872820) - FDA 510(k) Clearance

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

K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · General Hospital
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Sep 1987
Decision
50d
Days
Class 2
Risk

K872820 is an FDA 510(k) clearance for the SAFETY SYRINGE. 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 September 4, 1987 after a review of 50 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K872820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1987
Decision Date September 04, 1987
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 222
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K872820.
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
ADDITIVE EXTENSION SYRINGE
K853120 · Abbott Laboratories · Dec 1985
MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES
K852544 · Sherwood Medical Co. · Jul 1985