Cleared Traditional

IRRIGATION TRAY WITH PISTON SYRINGE (K942221) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K942221 · Trinity Laboratories, Inc. · General Hospital
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Aug 1994
Decision
91d
Days
Class 2
Risk

K942221 is an FDA 510(k) clearance for the IRRIGATION TRAY WITH PISTON SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Salisbury, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 91 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 Trinity Laboratories, Inc. devices

Submission Details

510(k) Number K942221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received May 06, 1994
Decision Date August 05, 1994
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 246
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K942221.
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824 · Stryker Corp. · Aug 1995
MONOJECT(R) PISTON SYRINGES
K945715 · Sherwood Medical Co. · Mar 1995
SYRINGE
K942615 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1994
MEDSAVER SYRINGE
K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994