Cleared Traditional

K942548 - JENNINGS JAVELIN

K942548 is an FDA 510(k) clearance for JENNINGS JAVELIN, manufactured by Jfi Endineering, Inc.. The device is a Class 2 General & Plastic Surgery device with product code FMK cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K942548 · Jfi Endineering, Inc. · General & Plastic Surgery device
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Nov 1994
Decision
156d
Days
Class 2
Risk

K942548 is an FDA 510(k) clearance for the JENNINGS JAVELIN. Classified as Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature (product code FMK), Class II - Special Controls.

Submitted by Jfi Endineering, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 3, 1994 after a review of 156 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Jfi Endineering, Inc. devices

FDA 510(k) Submission Details - K942548

510(k) Number K942548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1994
Decision Date November 03, 1994
Days to Decision 156 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 115d · This submission: 156d
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 K942548.
PLANCET
K113513 · Micropoint Technologies Pte, Ltd. · Jul 2012
ON CALL CHOSEN LANCING DEVICE
K113332 · ACON Laboratories, Inc. · Apr 2012
L1-PRO SYSTEM
K041665 · Pelikan Technologies, Inc. · Jul 2004
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