Cleared Traditional

K942221 - IRRIGATION TRAY WITH PISTON SYRINGE

K942221 is an FDA 510(k) clearance for IRRIGATION TRAY WITH PISTON SYRINGE, manufactured by Trinity Laboratories, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

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

FDA 510(k) Submission Details - K942221

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
Combination Product No
PCCP Authorized No
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.

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 337
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K942221.
DISPOSABLE 1CC SYRINGE WITH LUER LOCK
K945588 · Interventional Therapeutics Corp. · Feb 1995
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DRUG RECONSTITUTION FILTER DEVICE
K941020 · Gelman Sciences, Inc. · Aug 1994
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MEDSAVER SYRINGE
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UNKNOWN
K941032 · Gelman Sciences, Inc. · May 1994