Cleared Traditional

K991680 - SOFTINJECT

K991680 is an FDA 510(k) clearance for SOFTINJECT, manufactured by Androsystems Srl. The device is a Class 2 General Hospital device with product code KZH cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K991680 · Androsystems Srl · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
17d
Days
Class 2
Risk

K991680 is an FDA 510(k) clearance for the SOFTINJECT. Classified as Introducer, Syringe Needle (product code KZH), Class II - Special Controls.

Submitted by Androsystems Srl (Rome, IT). The FDA issued a Cleared decision on June 3, 1999 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6920 - 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 Androsystems Srl devices

FDA 510(k) Submission Details - K991680

510(k) Number K991680 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1999
Decision Date June 03, 1999
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KZH Device Classification - Class 2, Special Controls

Product Code KZH Introducer, Syringe Needle
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6920
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 - KZH Introducer, Syringe Needle

All 13
Devices cleared under the same product code (KZH) and FDA review panel - the closest regulatory comparables to K991680.
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QUICK-SERTER, MODEL 395
K992300 · Medtronic Minimed · Jul 1999
AUTO-INJECTOR, SURE-INJECT 2000
K981266 · Mighty Mo, Corp. · Jul 1998
B-D AUTO-INJECTOR
K974678 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1998
COPAXONE (GLATIRAMER ACETATE FOR INJECTION) EZ-JECT FROM SHARED SOLUTIONS
K974171 · Teva Medical, Ltd. · Dec 1997