Cleared Traditional

K915780 - RACK AND SYRINGES

K915780 is an FDA 510(k) clearance for RACK AND SYRINGES, manufactured by Normeca Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 400-day FDA review.

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

FDA 510(k) Submission Details - K915780

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.

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 536
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
PRIMARY SURGICAL DRESSING TRAY
K922041 · Transidyne General Corp. · Nov 1992