Cleared Traditional

K990020 - TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC

K990020 is an FDA 510(k) clearance for TE ME NA LOSS OF RESISTANCE SYRINGE, manufactured by Te ME NA S.A.R.L.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K990020 · Te ME NA S.A.R.L. · General Hospital
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Jun 1999
Decision
171d
Days
Class 2
Risk

K990020 is an FDA 510(k) clearance for the TE ME NA LOSS OF RESISTANCE SYRINGE, 10CC. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Te ME NA S.A.R.L. (Clearwater, US). The FDA issued a Cleared decision on June 24, 1999 after a review of 171 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 Te ME NA S.A.R.L. devices

FDA 510(k) Submission Details - K990020

510(k) Number K990020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date June 24, 1999
Days to Decision 171 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
42d slower than avg
Panel avg: 129d · This submission: 171d
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 387
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K990020.
SEALOUETTE FIBRIN SEALANT APPLICATOR
K992351 · Biosurgical Corp. · Oct 1999
TERUMO U-100 INSULIN SYRINGE
K992802 · Terumo Medical Corp. · Sep 1999
MTI 1 ML SYRINGE
K991225 · Micro Therapeutics, Inc. · Jul 1999
MONOJECT INSULIN SYRINGE
K991758 · The Kendal Co. · Jun 1999
EASYSAFE RETRACTING NEEDLE SYRINGE
K991039 · Saf-T-Med, Inc. · May 1999
ALLISON MEDICAL INSULIN SYRINGE (AMIS)
K984017 · Allison Medical, Inc. · Mar 1999