Cleared Traditional

K991039 - EASYSAFE RETRACTING NEEDLE SYRINGE

K991039 is an FDA 510(k) clearance for EASYSAFE RETRACTING NEEDLE SYRINGE, manufactured by Saf-T-Med, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K991039 · Saf-T-Med, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
53d
Days
Class 2
Risk

K991039 is an FDA 510(k) clearance for the EASYSAFE RETRACTING NEEDLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Saf-T-Med, Inc. (Barrington, US). The FDA issued a Cleared decision on May 21, 1999 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Saf-T-Med, Inc. devices

FDA 510(k) Submission Details - K991039

510(k) Number K991039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1999
Decision Date May 21, 1999
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
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 370
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K991039.
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
DISETRONIC PEN
K982966 · Disetronic Medical Systems · Oct 1998
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998
BECTON DICKINSON SYRINGES
K980580 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1998