Cleared Traditional

K881980 - RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRA...

K881980 is the FDA 510(k) clearance for RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRA... by Habley Medical Technology Corp.. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K881980 · Habley Medical Technology Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1988
Decision
47d
Days
Class 2
Risk

K881980 is an FDA 510(k) clearance for the RETROJECT(TM) ANTI-AIDS SYRINGE W/RETRAC. NEEDLE. 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 June 28, 1988 after a review of 47 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

Submission Details

510(k) Number K881980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1988
Decision Date June 28, 1988
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 294
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K881980.
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · Manan Medical Products, Inc. · Sep 1988
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · Medex, Inc. · Aug 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963 · Buckman Co., Inc. · Jun 1988
DISPOSABLE SYRINGE
K882335 · Baxter Healthcare Corp · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988