Cleared Traditional

K924511 - MONOJECT(R) 6 CC SAFETY SYRINGE

K924511 is an FDA 510(k) clearance for MONOJECT 6 CC SAFETY SYRINGE, 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 328-day FDA review.

K924511 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
328d
Days
Class 2
Risk

K924511 is an FDA 510(k) clearance for the MONOJECT(R) 6 CC SAFETY SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on July 29, 1993 after a review of 328 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K924511

510(k) Number K924511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1992
Decision Date July 29, 1993
Days to Decision 328 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
199d slower than avg
Panel avg: 129d · This submission: 328d
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 483
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K924511.
RIVER VIAL ADAPTER
K933335 · River Medical, Inc. · Mar 1994
ONE TIME VIAL ACCESS SPIKE
K934561 · Icu Medical, Inc. · Feb 1994
SPRING LOADED SYRINGE
K931095 · Acacia, Inc. · Sep 1993
FIBRACOL COLLAGEN-ALGINATE DRESSING
K925548 · Johnson & Johnson Medical, Inc. · Jul 1993
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993