Cleared Traditional

K922522 - MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES

K922522 is an FDA 510(k) clearance for MONOJECT 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 181-day FDA review.

K922522 · Sherwood Medical Co. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
181d
Days
Class 2
Risk

K922522 is an FDA 510(k) clearance for the MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES. 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 November 25, 1992 after a review of 181 days - an extended review 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: 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

FDA 510(k) Submission Details - K922522

510(k) Number K922522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date November 25, 1992
Days to Decision 181 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
52d slower than avg
Panel avg: 129d · This submission: 181d
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 484
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K922522.
BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD.
K930321 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1993
BECTON DICKINSON ARTERIAL BLOOD GAS KITS
K930342 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1993
BECTON DICKINSON SAFETY-LOK SYRINGE
K924072 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1992
PRIMARY SURGICAL DRESSING TRAY
K922041 · Transidyne General Corp. · Nov 1992
LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K922190 · Advanced Surgical, Inc. · Oct 1992
VISITEC ASPIRATING SYRINGE
K923645 · Visitec Co. · Sep 1992