Cleared Traditional

K820716 - MONOJECT 512 SYRINGES W/WO NEEDLES

K820716 is an FDA 510(k) clearance for MONOJECT 512 SYRINGES W/WO NEEDLES, manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K820716 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1982
Decision
30d
Days
Class 2
Risk

K820716 is an FDA 510(k) clearance for the MONOJECT 512 SYRINGES W/WO NEEDLES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1982 after a review of 30 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.

FDA 510(k) Submission Details - K820716

510(k) Number K820716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1982
Decision Date April 14, 1982
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 755
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K820716.
DISPOSABLE PLASTIC SYRINGE W/NEEDLE
K821233 · Taiyang Corp. · May 1982
GLASS SYRINGES, DRUG, LUER LOCK
K820384 · Procedure Products, Inc. · Apr 1982
COLORLESS DISPOSIBLE PLASTIC SYRINGES
K813157 · Sam Joo Industrial Co., Ltd. · Apr 1982
DISPOSABLE PLASTIC SYRINGE & NEEDLE
K820062 · Marshall Davis, Inc. · Apr 1982
BOSTON SYRINGE
K820294 · Frisco Products, Inc. · Mar 1982
PHARMACEUTICALS MOD. 1CC-1,2,3 THRU 50CC
K820449 · Abek Corp. · Mar 1982
K820716 · MONOJECT 512 SYRINGES W/WO NEEDLES
Download PDF Sherwood Medical Co.