Cleared Traditional

K883033 - PISTON SYRINGE WITH NEEDLE

K883033 is the FDA 510(k) clearance for PISTON SYRINGE WITH NEEDLE by Select Sources, Inc.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K883033 · Select Sources, Inc. · General Hospital
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Oct 1988
Decision
104d
Days
Class 2
Risk

K883033 is an FDA 510(k) clearance for the PISTON SYRINGE WITH NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Select Sources, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 31, 1988 after a review of 104 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Select Sources, Inc. devices

Submission Details

510(k) Number K883033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1988
Decision Date October 31, 1988
Days to Decision 104 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
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 294
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K883033.
30-CS01, 30-CS02, 30-CS03 CONTROL SYRINGES
K894801 · Advance Medical Designs, Inc. · Sep 1989
NEEDLE*LESS DRUG VIAL ADAPTER
K894177 · Baxter Healthcare Corp · Sep 1989
DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN
K890082 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1989
SINGLE-FIL(TM) SYRINGE
K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988