Cleared Abbreviated

K070936 - WELMED HYPODERMIC SYRINGE

K070936 is an FDA 510(k) clearance for WELMED HYPODERMIC SYRINGE, manufactured by Welmed, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Abbreviated 510(k) pathway after a 104-day FDA review.

K070936 · Welmed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
104d
Days
Class 2
Risk

K070936 is an FDA 510(k) clearance for the WELMED HYPODERMIC SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Welmed, Inc. (Mosely, US). The FDA issued a Cleared decision on July 16, 2007 after a review of 104 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Welmed, Inc. devices

FDA 510(k) Submission Details - K070936

510(k) Number K070936 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2007
Decision Date July 16, 2007
Days to Decision 104 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 129d · This submission: 104d
Pathway characteristics
Standards-based clearance path.

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 388
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K070936.
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007
GENIE, MODEL CH-200
K070633 · Icu Medical, Inc. · Jun 2007
50 ML TERUMO SYRINGE FOR ADMINISTRATION OF UV SENSITIVE MEDICINES, MODEL BS-50LB
K070264 · Terumo Europe N.V. · May 2007