Cleared Traditional

K871007 - ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE

K871007 is an FDA 510(k) clearance for ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO..., manufactured by Habley Medical Technology Corp.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K871007 · Habley Medical Technology Corp. · General Hospital
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Apr 1987
Decision
48d
Days
Class 2
Risk

K871007 is an FDA 510(k) clearance for the ANTI NEEDLE STRIKE ANTI DRUG ABUSE HYPO. SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Habley Medical Technology Corp. (Laguana Hills, US). The FDA issued a Cleared decision on April 30, 1987 after a review of 48 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 Habley Medical Technology Corp. devices

FDA 510(k) Submission Details - K871007

510(k) Number K871007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1987
Decision Date April 30, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
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 523
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K871007.
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
LOOK SPRING-ASSIST SYRINGES
K872944 · Look, Inc. · Sep 1987
MONOJECT PHARMACY TRAY
K860688 · Sherwood Medical Co. · Aug 1987
SURGITEK PHYSICIAN DISPEN. PATIENT SELF-INJECT KIT
K870518 · Surgitek · Apr 1987
ACCUPEN(R)
K870078 · Ulster Scientific, Inc. · Mar 1987
REFILLABLE SYRINGE
K864407 · Med Fusion Systems, Inc. · Jan 1987