Cleared Traditional

K820716 - MONOJECT 512 SYRINGES W/WO NEEDLES

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

K820716 · Sherwood Medical Co. · General Hospital
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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.

View all Sherwood Medical Co. devices

Submission Details

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.

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K820716.
LARYNGEAL SYRINGE
K822185 · Kelleher Corp. · Oct 1982
U-100 INSULIN SYRINGE
K822083 · Terumo Medical Corp. · Aug 1982
MONOJET 520 20CC SYRINGES W/NEEDLES
K822029 · Sherwood Medical Co. · Jul 1982
THE RED CAP
K820454 · Burron Medical Products, Inc. · Mar 1982
MONOJECT M560 60CC SYRINGES
K813480 · Sherwood Medical Co. · Jan 1982
20CC GLASS CONTROL SYRINGE
K813175 · Abco Dealers, Inc. · Nov 1981