Cleared Traditional

RACK AND SYRINGES (K915780) - FDA 510(k) Clearance

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

K915780 · Normeca Corp. · General Hospital
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Jan 1993
Decision
400d
Days
Class 2
Risk

K915780 is an FDA 510(k) clearance for the RACK AND SYRINGES. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Normeca Corp. (Skaarer, NO). The FDA issued a Cleared decision on January 27, 1993 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Normeca Corp. devices

Submission Details

510(k) Number K915780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1991
Decision Date January 27, 1993
Days to Decision 400 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
271d slower than avg
Panel avg: 129d · This submission: 400d
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 228
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K915780.
ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY
K930847 · Sherwood Medical Co. · Jul 1993
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
MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES
K922522 · Sherwood Medical Co. · Nov 1992
ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD
K921833 · Ethicon, Inc. · Sep 1992