Cleared Traditional

K944948 - FREE-LANCE

K944948 is an FDA 510(k) clearance for FREE-LANCE, manufactured by F.F.F. Enterprises, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K944948 · F.F.F. Enterprises, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
41d
Days
Class 2
Risk

K944948 is an FDA 510(k) clearance for the FREE-LANCE. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by F.F.F. Enterprises, Inc. (Temecula, US). The FDA issued a Cleared decision on November 17, 1994 after a review of 41 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4850 - the FDA general and plastic surgery 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 F.F.F. Enterprises, Inc. devices

FDA 510(k) Submission Details - K944948

510(k) Number K944948 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1994
Decision Date November 17, 1994
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 115d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMK Device Classification - Class 2, Special Controls

Product Code FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4850
Definition A Disposable Blood Lancet Intended For A Single Use That Is Comprised Of A Single Use Blade Attached To A Solid, Non-reusable Base (including An Integral Sharps Injury Prevention Feature) That Is Used To Puncture The Skin To Obtain A Drop Of Blood For Diagnostic Purposes. The Integral Sharps Injury Prevention Feature Allows The Device To Be Used Once And Then Renders It Inoperable And Incapable Of Further Use.
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

All 82
Devices cleared under the same product code (FMK) and FDA review panel - the closest regulatory comparables to K944948.
PLANCET
K113513 · Micropoint Technologies Pte, Ltd. · Jul 2012
ON CALL CHOSEN LANCING DEVICE
K113332 · ACON Laboratories, Inc. · Apr 2012
L1-PRO SYSTEM
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FEATHER-TOUCH SINGLE-STICK DEVICE
K942620 · Ulster Scientific, Inc. · Jun 1994
SOFTTOUCH II LANCET DEVICE
K931258 · Boehringer Mannheim Corp. · Feb 1994
BABISTICK
K933365 · Graphic Controls Corp. · Oct 1993