Cleared Traditional

K922522 - MONOJECT SAFETY SYRINGE

K922522 is the FDA 510(k) clearance for MONOJECT SAFETY SYRINGE by Sherwood Medical Co.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 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
VISITEC ASPIRATING SYRINGE
K923645 · Visitec Co. · Sep 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833 · Ethicon, Inc. · Sep 1992
IRRIGATING SYRINGE
K912437 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1992