Cleared Traditional

K945715 - MONOJECT PISTON SYRINGES

Also marketed or referenced as:
3,6,12,20,35 AND 60CC SIZES

K945715 is the FDA 510(k) clearance for MONOJECT PISTON SYRINGES by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K945715 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
100d
Days
Class 2
Risk

K945715 is an FDA 510(k) clearance for the MONOJECT(R) PISTON SYRINGES. 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 March 1, 1995 after a review of 100 days - within the typical 510(k) review window.

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 Sherwood Medical Co. devices

Submission Details

510(k) Number K945715 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1994
Decision Date March 01, 1995
Days to Decision 100 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
29d faster than avg
Panel avg: 129d · This submission: 100d
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 K945715.
PISTON SYRINGE
K951025 · Pharmacia, Inc. · Oct 1995
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824 · Stryker Corp. · Aug 1995
IRRIGATION TRAY WITH PISTON SYRINGE
K942221 · Trinity Laboratories, Inc. · Aug 1994
SYRINGE
K942615 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1994
MEDSAVER SYRINGE
K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994