Cleared Traditional

STERAID DISPOSABLE SYRINGE (K904620) - FDA 510(k) Clearance

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

K904620 · Disposable Medi-Aids , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
155d
Days
Class 2
Risk

K904620 is an FDA 510(k) clearance for the STERAID DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Disposable Medi-Aids , Ltd. (Areadina, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 155 days - an extended review 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: 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 Disposable Medi-Aids , Ltd. devices

Submission Details

510(k) Number K904620 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1990
Decision Date March 15, 1991
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 231
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K904620.
B-D INTERLINK SYRINGE CANNULA
K920422 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
BECTON DICKINSON SAFETY-LOK SYRINGE
K920321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1992
B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204
K912330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1991
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