Cleared Traditional

DISPO. AES DISPOS. SYRINGE W/NEEDLE (K841931) - FDA 510(k) Clearance

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

K841931 · Hirsch Chemie , Ltd. · General Hospital
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Jul 1984
Decision
56d
Days
Class 2
Risk

K841931 is an FDA 510(k) clearance for the DISPO. AES DISPOS. SYRINGE W/NEEDLE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Hirsch Chemie , Ltd. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1984 after a review of 56 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 Hirsch Chemie , Ltd. devices

Submission Details

510(k) Number K841931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1984
Decision Date July 06, 1984
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
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 240
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K841931.
MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES
K851089 · Sherwood Medical Co. · Apr 1985
MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE
K851090 · Sherwood Medical Co. · Apr 1985
SYRINGE W/NEEDLE COMBIN & SYRINGE ONLY
K844106 · Abco Dealers, Inc. · Jan 1985
HYPODERMIC SYRINGES & NEEDLES
K834548 · Cordis Corp. · Mar 1984
DIRECTOR
K832658 · Pharmacia, Inc. · Oct 1983
U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982